Two Food Importers Cited for Not Having FSVP

Two food importers were issued Warning Letters for non-compliance with Foreign Supplier Verification Program (FSVP). Like many of the other importers who are sighted, these two importers did not have a program in place. As you know, the FSVP requires that companies conduct a hazard analysis for the products they import and then verify controls are in place for any identified significant hazard controlled by the foreign company.

Kyawkhin Inc., Fort Wayne, IN, did not develop, maintain, and follow an FSVP, as required by section 805 of the FD &C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any foods that you import, including the following foods:

• Balachong fried chili paste imported from (b)(4), located in (b)(4)
• Peanut snack imported from (b)(4), located in (b)(4)
• Cypro tone beverage base imported from (b)(4), located in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kyawkhin-inc-666164-09202023

Distribuidora Jocorena Inc. Deer Park, NY did not develop an FSVP for any of the foods that you import, including the following foods:

• Pinole (corn flour) imported from (b)(4), located in (b)(4)
• Frozen corn tamale imported from (b)(4), located in (b)(4)
• Dry red beans (kidney beans) imported from (b)(4), located in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/distribuidora-jocorena-inc-669434-11302023

TX Food Warehouse Issued Warning Letter for Excessive Rodent Activity

FDA issued a Warning Letter to US Gulf Coast Trading Co, a refrigerated, frozen, and ambient food product warehouse located at in Houston, TX.  The primary issue was the lack of pest control, specifically for rodents.

Pest Control

• The biggest concern is the evidence of excessive rodent activity "including rodent excreta pellets (REPs) in numbers too numerous to count (TNTC), gnaw marks in food and food packaging, nesting material, live maggots, and other apparent excrement throughout your facility, including areas where human food is routinely stored"

Facility Maintenance

• Gaps were observed along the bottom, (b)(4), and top of the (b)(4) bay door when the door was fully closed. The roll-up door opens directly to the exterior (b)(4) of the warehouse, which could allow for the entrance of pests into the facility. Food products such as packaged tortillas, (b)(4), herbal tea, and stuffed eggplant were stored directly approximately 3 feet to this bay door.

Cleaning

• Did not clean non-food contact surface in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination,

Improper Storage

• Did not store food under conditions that protect against contamination of food, as required by 21 CFR § 117.93. Specifically, on August 7-10 and 15, 2023, the (b)(4) bay door, (b)(4) bay door, and entry door into the warehouse in the (b)(4) of the (b)(4) wall remained open when not in use and for extended periods. These conditions could allow for the entrance of pests into the facility, which may cause contamination of food products stored inside the warehouse.

Grounds

• On August 7-10 and 15, 2023, numerous empty pallets being stored directly against the exterior corner of the (b)(4) wall, directly adjacent to the (b)(4) bay door, which remained open when not in use and for extended periods of time during the inspection.
• On August 7-10 and 15, 2023, the grass and weeds located at the back and east side of the facility were observed to be overgrown that may lead to the harborage of pests.

Chemical Storage

• Did not store a toxic chemical in a manner that protects against contamination, as required by 21 CFR § 117.35(b)(2). Specifically, on August 7-10, 2023, a container of insect killer was observed being stored directly adjacent to a pallet containing boxes of jarred jam and canned olives at the end of row (b)(4) of the warehouse and 20 lb. sacks of steamed basmati rice approximately 8 ft. away along the (b)(4) wall of the warehouse.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-gulf-coast-trading-co-inc-668767-12052023
WARNING LETTER

US Gulf Coast Trading Co., Inc.
MARCS-CMS 668767 — DECEMBER 05, 2023

Warning Letter Issued to KY Bakery Detail Lack of GMPs

In a Warning Letter issued by FDA to a small KY desert company, Deserts by Hellen, FDA identified numerous GMP issues that demonstrate a lack of proper sanitary controls.    This is often an issue for  small retail operations that grow to where they want to distribute product - it exposes this lack of understanding of what is expected from a GMP perspective.

Handwashing / glove usage

• Two employees wearing gloves retrieved RTE chocolate cakes from the walk-in freezer. They touched the door handles, the interior surface of the walk-in freezer door, and plastic strip curtains that had a build-up of visible residue. The employees then touched the RTE chocolate cakes without washing and sanitizing their hands and changing their gloves. The employee then scooped chocolate sprinkles by hand, wearing the same gloves, and coated the cake with chocolate sprinkles.
• During the manufacturing of RTE Mile High Chocolate Cake, an employee moved a trash can using their gloved hands, and then continued to apply chocolate sprinkles to the RTE cake without first washing and sanitizing their hands and changing their gloves.

Facilities (buildings, fixtures, and other physical facilities) 

• A metal storage shelf in the walk-in cooler was visibly unclean with a green and white substance, mold-like in appearance.
• Apparent food residue and apparent green and white mold-like substance on a (b)(4) plastic pallet located in the walk-in cooler. The (b)(4) plastic pallet held a (b)(4) bucket of “(b)(4) WHOLE CHERRY FILLING.”
• Standing brown liquid in the drainage basin located in the packaging room. The drainage basin also contained apparent dirt, concrete pieces, and pieces of cloth.
• Pitted floors throughout the facility; they were visibly unclean and missing sealant in multiple areas. This is a repeat observation from FDA’s April 2022 inspection.
• Unclean interior surfaces of the dishwashing machine with apparent mineral and food residue buildup. This is a repeat observation from FDA’s April 2022 inspection. Additionally, the water in the tank of the dishwashing machine was observed to contain food residue, that water is circulated and sprayed over the dishes as part of the wash/rinse process.

Sanitation

• Employees used a metal scoop and spatula stored in the drawers of a (b)(4) toolbox that were visibly unclean with apparent food residue to apply icing to RTE Mile High Chocolate Cake without cleaning and sanitizing the utensils prior to use.
• A buildup of food residue was observed on the interior sides and slicing blade of the cake slicer used to slice RTE Jalapeno Cornbread in the packaging room.
• A buildup of food residue on the underside, spindle and rear splash guard of the stand mixers being used to manufacture RTE chocolate buttercream icing and Jalapeno Cornbread batter.
• Food residue on the base, underside, locking lever and wheels of the batter dispensing machine located in the production room that was being used to manufacture RTE Jalapeno Cornbread batter.
• Build-up of food residue on the top shelf extending over the stove, the stove’s backsplash, and the exhaust hood above the stove. An employee used the stove to melt margarine in a metal pot. This is a repeat observation from FDA’s April 2022 inspection.
• Visibly unclean exteriors of various stand mixer bowls stored on metal shelving. An employee retrieved one such bowl and used it to manufacture Jalapeno Cornbread batter without cleaning and sanitizing the bowl prior to use.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desserts-helen-inc-659181-09112023
Desserts by Helen, Inc.

MARCS-CMS 659181 — SEPTEMBER 11, 2023

Warning Letter to Cheese Operation Highlights Insufficient Cleaning and Listeria Contamination

FDA issued a Warning Letter to a NY Cheese processor.  In brief, they were found to have an ongoing Listeria issue as identified in 2023 recall situation for Listeria as well as an recall in 2017.  During a June 2023 inspection of the facility, FDA found Listeria in the facility as well as identified many GMP issues related to cleaning and poor equipment.  The identified cleaning issues are those types of things that can be easy to perhaps overlook, or more likely, just accept as normal after seeing it over a long period of time.  (This is where an outside audit can help - providing a different set of eyes to see those things we have become accustomed to).

Positive LM Findings

• FDA laboratory analysis of environmental samples collected at the facility on June 21, 2023 confirmed that four (4) of fifty (50) environmental swabs were positive for LM and those collected on June 26, 2023 confirmed that four (4) of fifty six (56) environmental swabs were positive for LM. Of the positive findings, one (1) of the L. monocytogenes positive swabs was collected from the food contact surface of a cutting board that was being used to cut RTE Jersey Girl cheese.
• Furthermore, in 2017, New York State Department of Agriculture and Markets (NYSDAM) collected a finished product sample of your firm’s Toma Celena cheese (lot #51017) which tested positive for L. monocytogenes. In response to this finding, your firm tested (b)(4) lots of finished products and found two additional lots (lots #52417 and #60717) to be positive for L. monocytogenes.
• The environmental swabs collected at the facility during FDA’s most recent inspection and finished product samples from 2017 represent four (4) different strains of L. monocytogenes. None of them matched any clinical isolates. 
• Conclusion - "Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism."

Cleaning issues - the facility did not clean adequately clean environmental areas including food-contact surfaces

• "Old, white-yellow cheese/wax/salt-like residues from previous lots of cheese were observed on the stainless-steel and plastic tables in your waxing/drying room on June 21 and 26, 2023. These tables were being used to store wheels and blocks of drying cheese products. Thereafter on July 18, 2023, the same residues were observed on these tables.  The company stated they had cleaned and sanitized these tables three times and were unable to remove the residues, but the investigator was able to scrape off the residue from the table."
• "Investigators observed the underside of a stainless-steel table in the manufacturing room had a heavy buildup of black-brown mold-like or rust-like residues on its surface. This table is used to store raw milk cheese products."
• "Areas of black and black-brown mold-like residues on the walls and baseboards in the manufacturing room, where products are processed. Furthermore, environmental sub #62, which was taken from the floor/wall baseboard (containing these residues) in the manufacturing room on June 26, 2023, was found positive for L. monocytogenes."
• "Areas of black and black-brown mold-like substances on the door and around the door handle to the main cheese cave, where products are aged. Furthermore, environmental sub #57, which was collected from this door handle on June 26, 2023, was found positive for L. monocytogenes."
• "Areas of the floor in the manufacturing room, where your products are processed, were pitted, and had uneven and rough surfaces. Furthermore, environmental subs #61 and #91, which were taken from two different floor areas in the manufacturing room on June 26, 2023, were both found positive for L. monocytogenes."
• "The bottom of the door, inside the main cheese cave, where your products are aged, was flaking a tape-like material. Furthermore, environmental sub #2, which was collected from this surface on June 21, 2023, was found positive for L. monocytogenes."
• "Areas of the floor in the brine area in the main cheese cave, where products are aged, were pitted, and had uneven and rough surfaces. Furthermore, environmental sub #9, which was collected from this surface on June 21, 2023, was found positive for L. monocytogenes."
• "Buildup of water on the floor around the (b)(4) near the raw milk receiving room, where you intake the raw cow’s milk that is used to make your products. The company  stated that the (b)(4) has had a “constant leak”, and that this has been an ongoing issue."
•  "Areas of black and black-brown mold-like substances and exposed foam-like insulation on the ceiling in the (b)(4) cheese cave, which is where your products are aged."
• "A fan in the waxing/drying room that was blowing on cheese product was observed to be covered with a thick layer of dust."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cooperstown-cheese-company-llc-667551-11242023
WARNING LETTER
Cooperstown Cheese Company, LLC
MARCS-CMS 667551 — NOVEMBER 24, 2023

CO Establishment Recalls Ground Beef for E. coli O103 After Positive FSIS Testing

Scanga Meat Company, a Salida, Colorado establishment, is recalling approximately 563 pounds of ground beef products that may be contaminated with E. coli O103.  The raw ground beef products were produced on December 11, 2023.  The problem was discovered during routine FSIS testing and the sampling results showed the presence of E. coli O103. There have been no confirmed reports of illness due to consumption of these products.

https://www.fsis.usda.gov/recalls-alerts/scanga-meat-company-recalls-ground-beef-products-due-possible-e--coli-o103
Scanga Meat Company Recalls Ground Beef Products Due to Possible E. Coli O103 Contamination

WASHINGTON, Dec. 22, 2023 – Scanga Meat Company, a Salida, Colorado establishment, is recalling approximately 563 pounds of ground beef products that may be contaminated with E. coli O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Label Design Issue Results in Missing Fish Allergen from Kimchi Label

World Variety Produce, Inc. of Los Angeles, CA is recalling Melissa's Kimchi Hot 14 oz, because of mislabeling of allergen ingredient "Fish" was not listed in the ingredient panel within the allergen information panel.   The recall was as the result of an internal finding of an product artwork review by Melissa's Design/Artwork department which revealed that the printed artwork was mislabeled and did not have an allergen listing of "Fish". World Variety Produce, Inc. has ceased the production and distribution of the product as FDA, World Variety Produce, Inc. continues their investigation as to what caused the issue.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/world-variety-produce-inc-recalls-kimchi-hot-because-possible-health-risk
World Variety Produce, Inc. Recalls Kimchi Hot Because of Possible Health Risk
Summary
Company Announcement Date:  December 26, 2023
FDA Publish Date:  December 26, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Fish
Company Name:  World Varity Produce, Inc.
Brand Name:  World Varity Produce, Inc.
Product Description:  Melissa’s Hot Kimchi

Whole Foods Frozen Beer-Battered Fish Recalled for Undeclared Soy Allergen

Tampa Bay Fisheries, Dover, FL, is recalling one lot of frozen Whole Foods Beer Battered Pollock Fillets after it was discovered that the label failed to declare soy on the label, thus an undeclared allergen.  Product was distributed nationwide. There have been no reported cases of illness.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tampa-bay-fisheries-inc-dover-florida-voluntarily-recalling-1-lot-365-whole-foods-market-beer
Tampa Bay Fisheries, Inc. Dover, Florida is Voluntarily Recalling 1 Lot of 365 Whole Foods Market Beer Battered Pollock Fillets and 2 Lots of 365 Beer Battered Cod Fillet Due to an Undeclared Soy Allergen
Summary
Company Announcement Date:  December 22, 2023
FDA Publish Date:  December 23, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy
Company Name:  Tampa Bay Fisheries, Inc.
Brand Name:  365 WHOLE FOODS MART
Product Description:  Beer Battered Pollock and Cod Fillets

FDA Issues Health Warning About Oysters from Canada That Have Been Linked to Campylobacter Outbreak

The FDA is advising restaurants and food retailers not to serve or sell and to dispose of oysters and consumers not to eat oysters from Pacific Oyster Fanny Bay, harvested on 11/08/2023 from harvest area BC 14- 8 with Landfile # 1402294 and Oyster Malaspina Live, harvested on 11/09/2023 from harvest area BC 14-8 with Landfile # 278761 and shipped to distributors in Utah and Wisconsin because they may be contaminated with Campylobacter jejuni.

"On 12/18/2023, the Utah Shellfish Authority notified the FDA of two cases of Campylobacter connected to consumption of oysters from British Columbia, Canada. The FDA has notified the Canadian Food Inspection Agency (CFIA) of the illnesses and the CFIA is investigating. The two cases consumed oysters in Utah and Wisconsin and the FDA is coordinating with the CFIA and state authorities to determine if any additional distribution occurred.

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-restaurants-and-retailers-not-serve-or-sell-and-consumers-not-eat-certain-oysters?utm_medium=email&utm_source=govdelivery
FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Oysters from British Columbia, Canada Potentially Contaminated with Campylobacter jejuni

NC Issues Recalls for Kitten and Puppy Food After State Lab Detects Salmonella / Listeria

Blue Ridge Beef is recalling all lot numbers and used by dates between N24 1124 to N24 1224 of their 2 lb log of Kitten Grind UPC 8 54298 00101 6; 2lb log of Kitten Mix UPC 8 54298 00143 6 and their 2lb log of Puppy Mix UPC 8 54298 00169 6 due to contamination of Salmonella and Listeria monocytogenes. Salmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

On 12/15/2023 the firm was notified by the North Carolina Department of Agriculture and Consumer Services that one lot of each of the products were sampled and tested positive for Salmonella and Listeria monocytogenes. However, out of an abundance of caution the firm is recalling all lots with the used by dates between N24 1124 to N24 1224.

In October, this firm issued a recall for dog food due to Salmonella contamination.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-ridge-beef-issues-voluntary-recall-blue-ridge-beef-kitten-grind-blue-ridge-kitten-mix-and-blue
Blue Ridge Beef Issues Voluntary Recall of Blue Ridge Beef Kitten Grind, Blue Ridge Kitten Mix and Blue Ridge Beef Puppy Mix Due to Salmonella and Listeria Monocytogenes Contamination
Summary
Company Announcement Date:  December 21, 2023
FDA Publish Date:  December 21, 2023
Product Type:  Animal & Veterinary
Reason for Announcement:  Potential contamination of Salmonella and Listeria monocytogenes
Company Name:  Blue Ridge Beef
Brand Name:  Blue Ridge Beef
Product Description:  Kitten Grind, Kitten Mix, and Puppy Mix

Update on Lead in Cinnamon Apple Sauce, Now Over 200 Reported Cases and A Concern for Those Impacted Children

CDC reports that there are 205 reported reports of adverse events linked to the lead-contaminated cinnamon apple sauce.  Initially reported in late October along with the issuance of associated product, the investigation continues.  Cinnamon samples from the facility show an extremely high level of lead in the product.

"FDA’s onsite inspection of the Austrofoods facility in Ecuador has ended. However, the FDA investigation of the elevated lead levels in recalled cinnamon applesauce pouches continues. During the inspection, investigators collected samples of cinnamon supplied by Negasmart to Austrofoods. These samples have undergone analysis and results show extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm. For context, the international standard-setting body, Codex Alimentarius Commission (Codex)External Link Disclaimer is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024."

CDC has received the following reports from state and local health departments:

• Total Cases: 205
• Confirmed Cases: 67
• Probable Cases: 122
• Suspect Cases: 16
• States: (33 total) AL, AR, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, ND, NE, NH, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI, WV
• Recall: Yes

A concern for those children who consumed that product.  "Tests show victims had blood lead readings up to eight times higher than the federal reference level of concern, health officials said. Samples of the puree showed lead contamination more than 200 times higher than the FDA allows."  Children will need to be monitored for long term impact.

This contamination issue, according to FDA, is likely due to adulteration.  "Spices such as turmeric, cinnamon and paprika have been known to be mixed with lead chromate or lead oxide, compounds that mirror the spices' colors, said Karen Everstine, technical director for FoodchainID, a company that tracks food supply chains."  “The intent is not to make people sick. Nobody wants to do that because then they get caught,” Everstine said. “What they want to do is make money.”

The import of this product does fall under regulation.  The foreign company manufacturing the product would be operating under Preventive Controls for Human Foods, and the importer would have to comply with the Foreign Supplier Verification program.  Most of this however, focuses on known hazards.  Intentional adulteration can be more difficult to control, especially when it occurs at a foreign manufacturer using an ingredient from a foreign source that does not enter the US.


Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.
Content current as of: 12/19/2023
Current Update
December 19, 2023

Chocolate Bars Recalled for Undeclared Coconut Due to Packaging Error

Astor Chocolate Corporation of Lakewood, New Jersey is recalling 1,092 Burnt Caramel Candy Bars, because it may contain undeclared coconut.   The recall was initiated after it was discovered that the coconut-containing product was distributed in packaging that did not reveal the presence of coconut.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astor-chocolate-corporation-issues-allergy-alert-undeclared-coconut-burnt-caramel-bars
Astor Chocolate Corporation Issues Allergy Alert on Undeclared Coconut in Burnt Caramel Bars
Summary
Company Announcement Date:  December 21, 2023
FDA Publish Date:  December 21, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential Allergen – Undeclared Coconut
Company Name:  Astor Chocolate Corporation
Brand Name:  Chocew
Product Description:  Burnt Caramel Candy Bars

Food Science Trends for 2024

IFT (Institute of Food Technologist) provided a post on trends for 2024.  They identified four.  In summary:

Food systems approaches: Farm to Fork strategy - the interconnectedness of the food supply with a focus on sustainability and reduction of food waste.

Food as Medicine: The Food as Medicine movement - As research continues, there will be more discussion on the impact of food on health.  I think the CBD movement will also come more into focus as more research comes out.

Food safety: Ongoing, visible food safety concerns - The big focus here will be on micro-chemicals in the food supply

Artificial intelligence - There will be positives such as using AI to optimize the supply chain provide new discoveries and there will be negatives - like robots doing my job...just kidding, kind of.

What do you think?

One challenge that I would add is the ongoing impact of a turbulent economy on prices, wages, employment shortages, and imbalances in supply and demand.  

https://www.ift.org/news-and-publications/blog/2023/ifts-science-and-policy-team-identifies-four-trends-for-2024
IFT's Science and Policy Team Identifies Four Trends for 2024

From rapid changes ushered in by artificial intelligence to the emergence of stronger policies linking medicine and nutrition, our experts pinpoint next year's top science of food trends.

As we look ahead to 2024, IFT’s Science and Policy team has forecasted four major science of food trends to watch for. On the horizon are the influence of Farm to Fork strategy on global food system dialogue, a growing Food as Medicine movement, ongoing improvements to the food safety landscape, and advancements in artificial intelligence. As always, creative food science solutions will be essential in delivering safe, nutritious, and sustainable foods, and we expect the science of food community to continue to play a leading role in tackling the challenges ahead. Read on for the most need-to-know trends for the coming year.

FDA Issues Warning Letters to Manufacturers / Distributors of Veterinary Products with Antimicrobials for Aquarium Fish

FDA issued a number of Warning Letters to companies that manufacture and/or distribute antimicrobial chemicals for treatment of aquarium fish.  And birds.  Wow, in an age where we are concerned about the overuse of antimicrobials, here is a whole sector where there is little control.

Drugs were not tested for use - These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are for use in nonfood-producing fish, which are minor species and are not the subject of a final FDA regulation finding either that the drugs are generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the drug’s labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met.

Companies are basically selling antibiotics over-the-counter - FDA is particularly concerned about your unapproved animal drugs because they raise public health concerns. Available as over-the-counter drugs, they contain antimicrobials that are considered medically important in the treatment of human disease.1 Concern about the development of resistance to antimicrobials important in human medicine has led FDA to promote more judicious use of animal drugs containing medically important antimicrobials, including working toward ensuring that these drugs can be used in animals only under the supervision of a licensed veterinarian.

Gift Baskets Utilizing Suspect Granola Bars Are Recalled

Wine Country Gift Baskets / Houdini Inc. of Fullerton, CA is taking precautionary measures of voluntarily recalling all gift baskets produced with Quaker Chewy Granola bars due to a recall by the Quaker Oats company because it has the potential to be contaminated with Salmonella


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/houdini-inc-recalls-gift-baskets-quaker-oats-chewy-granola-bars-because-possible-health-risk
Houdini, Inc. Recalls Gift Baskets with Quaker Oats Chewy Granola Bars Because of Possible Health Risk
Summary
Company Announcement Date:  December 19, 2023
FDA Publish Date:  December 19, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential Salmonella contamination
Company Name:  Houdini, Inc.
Brand Name:  Wine Country Gift Baskets
Product Description:  Gift Baskets with Quaker Chewy Granola Bars

WI Company Recalls Raspberry Pastry Product for Undeclared Pecans

Racine Danish Kringles of Racine, Wisconsin is recalling 960 units of Raspberry Kringle 14oz with lot code 23299 sold in select ALDI retail stores because the item may contain undeclared pecans.  The recall was initiated when a customer discovered that a Raspberry Kringle containing pecans was distributed in packaging that did not reveal the presence of pecans.  No illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rdk-corp-dba-racine-danish-kringles-issues-allergy-alert-potential-undeclared-pecans-14oz-raspberry
RDK Corp (DBA Racine Danish Kringles) Issues Allergy Alert on Potential for Undeclared Pecans in 14oz Raspberry Kringle
Summary
Company Announcement Date:  December 19, 2023
FDA Publish Date:  December 19, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Allergen - Pecans
Company Name:  RDK Corp
Brand Name:  Racine Danish Kringles
Product Description:  Raspberry Kringle Danish

Ark Establishment Recalls Boneless Chicken Bites After USDA-FSIS Received Consumer Complaints for Pieces of Hard Plastic

Simmons Prepared Foods Inc., a Van Buren, Ark. establishment, is recalling approximately 26,550 pounds of TGI Fridays boneless chicken bites products that may be contaminated with extraneous materials, specifically pieces of clear, hard plastic.  The problem was discovered when the firm notified FSIS that it had received consumer complaints reporting that clear, hard plastic was found under the breading of the boneless chicken bites.

https://www.fsis.usda.gov/recalls-alerts/simmons-prepared-foods-inc--recalls-boneless-chicken-bites-products-due-possible
Simmons Prepared Foods, Inc. Recalls Boneless Chicken Bites Products Due to Possible Foreign Matter Contamination

WASHINGTON, Dec. 15, 2023 - Simmons Prepared Foods Inc., a Van Buren, Ark. establishment, is recalling approximately 26,550 pounds of TGI Fridays boneless chicken bites products that may be contaminated with extraneous materials, specifically pieces of clear, hard plastic, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

Ohio Firm Recalls Deli Salad Items Due to Potential Listeria Contamination

Herold’s Salads of Cleveland is recalling assorted deli salads packaged in various sizes. Recalled products may be contaminated with Listeria monocytogenes.  There have been no reported illnesses or adverse health effects reported to date, however, Herolds Salads Inc. is proactively recalling specific batches to which this risk applies. 

Recalls of this nature often occur due to Listeria being found during testing, probably found in the processing environment.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/herolds-salads-inc-voluntarily-recalls-assorted-deli-salads-due-possible-contamination-listeria
Herolds Salads Inc. Voluntarily Recalls Assorted Deli Salads Due to Possible Contamination with Listeria monocytogenes
Summary
Company Announcement Date:  December 16, 2023
FDA Publish Date:  December 16, 2023  Updated on 12/20/23
Product Type:  Food & Beverages
Reason for Announcement:  Product may be contaminated with Listeria monocytogenes.
Company Name:  Herold’s Salads Inc.
Brand Name:  Multiple brand names
Product Description:  Various Deli Salads

Ohio Firm Recalls Cookie Bites for Undeclared Allergens

Eban’s Bakehouse is recalling all of its Sweet Indulgences cookie bites, packaged in 12-count, 11.85 oz boxes, due to undeclared milk and soy allergens. The labeling issue was discovered during a routine inspection conducted by the Ohio Department of Agriculture. There have been no reports of illness involving the products addressed in this recall.

The issue is that ingredients were not investigated and associated allergens identified.  For example, butter is listed, but the allergen milk was not identified.  The soy coming with the soy lecithin used in chocolate.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ebans-bakehouse-issues-voluntary-recall-due-undeclared-milk-and-soy-allergens
Eban’s Bakehouse Issues a Voluntary Recall Due to Undeclared Milk and Soy Allergens
Summary
Company Announcement Date:  December 16, 2023
FDA Publish Date:  December 16, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk and soy
Company Name:  Eban’s Bakehouse
Brand Name:  Eban’s Bakehouse
Product Description:  Cookie Bites

MA Firm Recalls Bagged Mung Bean Sprouts After State Lab Tests Finds Listeria

Chang Farm, Whatley, MA is recalling 12 oz Nature’s Wonder Mung Bean Sprouts, with the sell-by date of December 13th, 2023 because of the presence of Listeria monocytogenes (L. Monocytogenes).

The recall was initiated after a random sample was collected and analyzed by the Virginia Department of Agriculture and Consumer Services (VDACS), which resulted in confirmation of presence Listeria Monocytogenes in the product.
The product has been distributed to retail stores and wholesalers throughout MA, CT, NY and MD.
No illnesses have been reported to date.

The product is not labeled as RTE product.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/chang-farm-recalls-natures-wonder-mung-bean-sprouts-because-possible-health-risk
Chang Farm Recalls Nature’s Wonder Mung Bean Sprouts Because of Possible Health Risk
Summary
Company Announcement Date:  December 15, 2023
FDA Publish Date:  December 15, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Chang Farm
Brand Name:  Nature's Wonder
Product Description:  Mung Bean Sprouts

Bagged Fresh Spinach Recalled After State Lab Testing Finds Listeria

Fresh Express has issued a voluntary recall of a Fresh Express Spinach, 8 oz. size, with product code G332 and use-by date of December 15 and Publix Spinach, 9 oz size, with product code G332 and a now expired use-by date of December 14 due to a potential health risk from Listeria monocytogenes.
The recall was initiated after routine sampling conducted by the Florida Department of Agriculture yielded a positive result for Listeria monocytogenes in a single randomly selected package of spinach. Fresh Express immediately notified affected retailers and instructed them to remove the recalled items from store shelves and all inventories.  To date no illnesses are reported in connection with the recall and no other Fresh Express products are being recalled.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-announces-recall-limited-spinach-products-due-possible-health-risk
Fresh Express Announces Recall of Limited Spinach Products Due to Possible Health Risk
Summary
Company Announcement Date:  December 15, 2023
FDA Publish Date:  December 15, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Fresh Express
Brand Name:  Fresh Express & Publix
Product Description:  Spinach

Quaker Oats Recalls Granola Products Due to Potential Salmonella Contamination

The Quaker Oats Company today announced the recall of specific granola bars and granola cereals listed below because they have the potential to be contaminated with Salmonella.  
The products listed below are sold throughout the 50 United States, Puerto Rico, Guam and Saipan.
To date, Quaker has received no confirmed reports of illness related to the products covered by this recall.

While the company did not specifically state the reason for the recall, outside the fact that there were no reported illnesses, this would lead one to believe that it was perhaps a positive test result.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/quaker-recalls-granola-bars-and-granola-cereals-due-possible-health-risk
Quaker Recalls Granola Bars and Granola Cereals Due to Possible Health Risk
Summary
Company Announcement Date:  December 15, 2023
FDA Publish Date:  December 15, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential for Salmonella contamination
Company Name:  The Quaker Oats Company
Brand Name:  Quaker
Product Description:  Granola Bars and Granola Cereals

Cases of Lead Poisoning from Apple Sauce - Could This be the Result of Intentional Contamination?

As an update on the contaminated apple puree product that resulted in over 100 reported cases of lead poisoning cases in children, FDA’s Deputy Commissioner for Human Foods Jim Jones indicated to Politico that this may be a case of intentional contamination.  “We’re still in the midst of our investigation. But so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out,”  “My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.”

According to the article in Politico, the "FDA continues to investigate a number of theories for how the pouches became contaminated, and has not drawn any conclusions about the way the lead was added, why or by whom. The FDA says it currently believes the adulteration is “economically motivated.” That generally refers to ingredients being altered in order to make products appear higher in value, often so companies can produce a cheaper item and sell it at an elevated price."

Politico
https://www.politico.com/news/2023/12/14/applesauce-pouches-may-have-been-contaminated-on-purpose-fda-foods-chief-says-00131797
AGRICULTURE
Applesauce pouches may have been contaminated on purpose, FDA foods chief says

The food safety agency continues to investigate dozens of incidents of lead poisoning in U.S. children linked to three brands of cinnamon applesauce pouches.
By MARCIA BROWN and MEREDITH LEE HILL
12/14/2023 01:29 PM EST

FDA Advisory Issued for Clams Harvested from Unapproved Waters

FDA issued an advisory about not consuming Red’s Best chopped clams that were likely harvested from prohibited waters in MA on 11/25/2023 and 11/26/2023.  Clams harvested from prohibited waters may be contaminated with human pathogens, toxic elements or poisonous or deleterious substances and can cause illness if consumed. Clams are filter feeders that remove and bioaccumulate bacteria and other pathogens from the water. It is not uncommon for shellfish to be consumed raw and whole. 

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-restaurants-and-retailers-not-serve-or-sell-and-consumers-not-eat-certain-chopped-clams
FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Chopped Clams Likely Harvested from a Prohibited Area in Massachusetts and Distributed by Red’s Best

Salmonella-in-Diced-Onion Outbreak Over, Investigation Finds Salmonella at Farm

CDC declared the Salmonella outbreak associated with diced onions is now over. The onion product produced in August by Gill Onions of Oxnard CA, has cased 80 illnesses with 18 hospitalizations and 1 death. The product was recalled in October.

 "FDA collected multiple water, environmental, and product samples from the farm that supplied the contaminated onions to Gills Onions. Six of the samples, three water and three environmental, were positive for Salmonella spp. Whole Genome Sequencing (WGS) analysis confirmed that the strain of Salmonella found in isolates associated with three of the samples matched the same strain of Salmonella causing illnesses in this outbreak. Additional Salmonella isolates from the samples were detected, and CDC identified people who got sick with these strains of Salmonella. FDA and CDC partners reviewed the available data; however, there was not enough epidemiologic or traceback evidence to implicate a product or source of contamination for those illnesses."

Case Counts
Total Illnesses: 80
Hospitalizations: 18
Deaths: 1
Last Illness Onset: November 11, 2023
States with Cases: AZ, CA, CO, GA, ID, IL, IN, IA, KY, MA, MI, MT, NY, ND, OH, OR, TN, TX, UT, VA, WA, WI, WY
Foodservice Product Distribution*: Nationwide and Canada
Retail Product Distribution*: AZ, CA, ID, MT, OR, WA

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-onions-october-2023
Outbreak Investigation of Salmonella: Onions (October 2023)
FDA’s Investigation is complete. CDC declares outbreak over.
Current Update
December 13, 2023

WA State Establishment Recalls Beef Soup After Plant-based Chicken Label Applied

USDA FSIS issued a public health alert for ready-to-eat (RTE) product labeled as birria-inspired beef soup due to misbranding and an undeclared allergen due to mislabeling issue. The product labeled as birria-inspired beef soup may actually contain plant-based chicken noodle soup, which contains sesame,  an allergen, which is not declared on the product label.  The issue was discovered by the retailer after a store employee identified a case of RTE Plant-Based Chicken Noodle Soup product bearing the correct top label but incorrect front and back labels. 

Strange that Plant-Based Chicken Noodle Soup contains no chicken.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-beef-soup-product-due-misbranding-and-undeclared
FSIS Issues Public Health Alert for Beef Soup Product due to Misbranding and Undeclared Allergen

FRESH FOODS OF WASHINGTON LLC

Iowa Firm Recalls Candies for Undeclared Egg Allergens

Valley View Candies of Edgewood, IA is recalling All Fudge products - Peanut Butter Fudge, Maple Nut Fudge, Chocolate Fudge, Chocolate Walnut Fudge, because it may contain undeclared eggs.  The recall was initiated after it was discovered that the fudge products containing egg was distributed in packaging that did not reveal the presence of egg.   

The issue appears to be the fact that the recalled products all contain marshmallow cream, an item which will normally contains egg whites as an ingredient.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/valley-view-candies-issues-allergy-alert-undeclared-egg-fudge-products
Valley View Candies Issues an Allergy Alert on Undeclared Egg in Fudge Products
Summary
Company Announcement Date:  December 14, 2023
FDA Publish Date:  December 14, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared eggs
Company Name:  Valley View Candies
Brand Name:  Valley View Candies
Product Description:  Peanut Butter, Maple Nut, Chocolate, and Chocolate Walnut Fudge

Colorado Company Recalls Product Due to Undeclared Allergens Again

Bobo’s of Loveland, Colorado is issuing a voluntary recall of Bobo’s Peach Oat Bars because they may contain undeclared coconut.   The recall was initiated after it was discovered that product containing coconut was distributed in packaging that did not reveal the presence of coconut on the ingredient deck.

This is not the first boo-boo for Bobo's involving incorrect packaging leading to a allergen-related recall.  In 2021, there were two recalls, one for peanuts in Maple Pecan Bars, and the other was peanuts in Almond Butter Bars.  The well developed and implemented Allergen Preventive Control would ensure that labeling errors such as this not occur.

Bobo’s Issues a Voluntary Allergy Alert on Undeclared Coconut in Product
Summary
Company Announcement Date: December 09, 2023
FDA Publish Date:  December 12, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared coconut.
Company Name:  Bobo’s
Brand Name:  Bobo’s
Product Description:  Peach Oat Bars

Ill Dairy Recalls Non-Egg Egg Nog, Holiday Nog, for Containing Egg

Prairie Farms Dairy, Inc. of Edwardsville, ILL has initiated a voluntary recall on specific batches of private label Holiday Nog purchased in United Dairy Farmers stores between December 4th through December 6th, 2023, that may contain an undeclared egg allergen.  This specific batch may have been mis-labeled related to egg allergens

Prairie Farms Dairy, Inc. of Edwardsville, ILL has Initiated a Voluntary Recall on Specific Batches of Private Label Holiday Nog Purchased in United Dairy Farmers Stores Between December 4th Through December 6th, 2023, that May Contain an Undeclared Egg Allergen
Summary
Company Announcement Date:  December 08, 2023
FDA Publish Date:  December 08, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  Prairie Farms Dairy, Inc
Brand Name:  United Dairy Farmers
Product Description:  Holiday nog

FDA Warning Letter Highlights the Requirement for Reporting Non-compliant Product to Reportable Food Registry

In December of 2022, a feed facility of Nutra Blend, LLC subsidiary of Land O’Lakes., mistakenly added drug ingredient into a non-medicated feed which resulted in deaths of multiple calves. While FDA cited the company for issues with its Preventive Controls Plan, FDA also hit on the company for failing to report the non-compliant product into the Reportable Food Registry.  And this is an important regulation that may not be well known or can be overlooked.

What is the Reportable Food Registry?

• "The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect the public health by tracking patterns and targeting inspections." 
• Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption ...are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.
• Must provide amended reports as necessary- for example, FDA understands that it may take more than 24 hours to perform investigation activities and obtain information such as the results of any investigation of the root cause of the adulteration (when applicable) and the disposition of the reportable food.
• Portal - https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=938fc413-86cd-4670-8fe4-64e25d253c33

In this case, the company knew there was an issue, but fumbled around trying to determine how bad the issue was rather then getting notification out.  

"Furthermore, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that it is reportable (i.e., that there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals).5 Failure to submit a required reportable food report is a prohibited act."

"You tried to justify not filing an RFR while you asked the lab to reanalyze and provide the actual amount of monensin present in the sample and continued to assess with your nutritionists, veterinarians, and published data if the elevated level of ionophores would result in an animal health issue. However, this feed was not formulated to contain any monensin (an ionophore) and you were already aware the animals appeared to have died of ionophore toxicity."

As for the improper mixing issues:

Your root cause investigation found the source of the monensin to be the weighed and staged (b)(4) of monensin intended for the next product, Accuration Finisher 44 R227. Your mixing operator occasionally combines (b)(4) from (b)(4) pallets onto a single pallet to minimize time spent moving the ingredients to the mixer. In this instance, you determined the operator combined (b)(4) from the (b)(4) different work orders, then removed all the barcode tags from all staged (b)(4) and placed them near the scanner so they would be accessible when he was ready to scan them. This action left all the micro-ingredients for (b)(4) products unidentified, causing the operator to erroneously add the monensin to the incorrect product. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutra-blend-llc-subsidiary-land-olakes-651174-05222023
Nutra Blend, LLC subsidiary of Land O’Lakes
MARCS-CMS 651174 — MAY 22, 2023

Alabama Establishment Recalls RTE Chicken Products After Complaints for Being Undercooked

Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 1,377 pounds of ready-to-eat (RTE) chicken breast products that may be undercooked.  The problem was discovered when the firm received a customer complaint that the RTE chicken product appeared to be undercooked.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

https://www.fsis.usda.gov/recalls-alerts/wayne-farms-llc-recalls-ready-eat-chicken-breast-products-may-be-undercooked-0
Wayne Farms, LLC, Recalls Ready-to-Eat Chicken Breast Products That May Be Undercooked

WASHINGTON, Dec. 7, 2023 – Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 1,377 pounds of ready-to-eat (RTE) chicken breast products that may be undercooked, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Missouri Company Recalls Frozen Pizza for Undeclared Wheat Allergens

Shakespeare’s Pizza of Columbia, Missouri is recalling all its frozen pizzas from grocery stores, as they contain wheat, but do not declare the presence of wheat on their labels. A routine inspection by the  government regulatory agency partners brought to light the omission of a declaration on our labeling of the presence of wheat in the pizzas.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shakespeares-pizza-issues-allergy-alert-concerning-undeclared-wheat-its-frozen-pizzas
Shakespeare’s Pizza Issues an Allergy Alert Concerning Undeclared Wheat in Its Frozen Pizzas
Summary
Company Announcement Date:  December 07, 2023
FDA Publish Date:  December 08, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Shakespeare’s Pizza
Brand Name:  Shakespeare’s
Product Description:  Frozen pizza

Florida Man Suffers Cardiac Arrest After Consuming Highly Caffeinated Beverages

A 46 year old Florida man suffered a fatal cardiac arrest after drinking three Charged Lemonades from a local Panera this October.  Panera's Charged Lemonade is advertised as “Plant-based and Clean with as much caffeine as our Dark Roast coffee.” with 390 milligrams of caffeine.  The Food and Drug Administration says healthy adults can safely consume 400 milligrams of caffeine a day.

The man had an unspecified chromosomal deficiency disorder, a developmental delay and a mild intellectual disability as well as suffered from hypertensive disease.  The family filed a lawsuit against the company.

A UPenn student also died after drinking the beverage. She had an underlying condition, "a heart condition called long QT syndrome type 1 and avoided energy drinks based on her doctors’ recommendation"

NBC News
https://www.nbcnews.com/news/us-news/panera-breads-charged-lemonade-blamed-second-death-lawsuit-alleges-rcna128036?utm_medium=email&utm_source=rasa_io&utm_campaign=newsletter
Panera Bread’s Charged Lemonade blamed for a second death, lawsuit alleges

Dennis Brown, 46, drank three of the highly caffeinated beverages before suffering a cardiac arrest in October, according to the suit.

Dec. 4, 2023, 11:21 PM EST

By Elizabeth Chuck

Panera Bread’s highly caffeinated Charged Lemonade is now blamed for a second death, according to a lawsuit filed Monday.

TX Establishment Recalls RTE Chicken Fried Rice After Positive Listeria Test

Garland Ventures, a Garland, Texas, establishment, is recalling approximately 13,842 pounds of ready-to-eat (RTE) chicken fried rice products that may be adulterated with Listeria monocytogenes.  The problem was discovered by FSIS during review of testing results, which showed the product tested positive for L. monocytogenes.

https://www.fsis.usda.gov/recalls-alerts/garland-ventures-recalls-ready-eat-chicken-fried-rice-products-due-possible-listeria
Garland Ventures Recalls Ready-to-Eat Chicken Fried Rice Products due to Possible Listeria Contamination

FSIS Announcement

EDITOR’S NOTE: Dec. 6, 2023 - Details of this recall were updated to reflect the correct lot code for the product implicated in the recall.

WASHINGTON, Dec. 6, 2023 – Garland Ventures, a Garland, Texas, establishment, is recalling approximately 13,842 pounds of ready-to-eat (RTE) chicken fried rice products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

CA Company Recalls Noodle Product for Undeclared Peanuts

New India Bazar, Milpitas, CA is recalling 2,400 packets of Maggi 2 Minute Noodles 280g and 1,200 packets Maggi 2 Minute Noodles 560g, because it may contain undeclared Peanut allergen.  The recall was initiated after it was discovered that Maggie 2-minute noodle 280 grams and 560 grams Packaging contains peanuts, which was distributed in such packaging, and the packaging didn’t reveal the presence of peanuts.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alert-undeclared-peanut-maggi-2-minute-noodles
Allergy Alert for Undeclared Peanut in Maggi 2 Minute Noodles
Summary
Company Announcement Date:  December 01, 2023
FDA Publish Date:  December 04, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Undeclared peanuts
Brand Name:  Maggi
Product Description:  2 Minute Noodles

Iowa Firm Recalls Cake Products Due to Undeclared Allergens

Lara’s Bakery 3 LLC of Marshalltown, IA is recalling Pan de Racho, Panque, and Pan Surtido (Concha, Cema, Polvoron, Flan, Chocoflan, Tres Leches, Tostado de Guatemala, Pan de Guatemala, Canasta, Garibaldi, Marianas, Muffin, Pan Fino, Pastel de Glass, Pan de Trigo, Puerco, Bolillo, Telera), because it contains undeclared sesame seed, coconut, soy, wheat, milk, and egg.  The recall was initiated after it was discovered that products containing sesame, coconut, soy, wheat, milk, and eggs were distributed in packaging that did not reveal the presence of these allergens. The product had already been distributed to retail stores in the state of Iowa and Wisconsin


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/laras-bakery-3-llc-issues-allergy-alert-undeclared-sesame-seed-coconut-soy-wheat-milk-and-eggs-pan
Lara’s Bakery 3 LLC, Issues Allergy Alert on Undeclared (Sesame Seed, Coconut, Soy, Wheat, Milk and Eggs) in Pan de Racho, Panque, Tres Leches, Chocoflan and Pan Surtido
Summary
Company Announcement Date:  December 05, 2023
FDA Publish Date:  December 04, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sesame seed, coconut, soy, wheat, milk, and egg
Company Name:  Lara’s Bakery 3, LLC.
Brand Name:  Lara’s Bakery 3
Product Description:  Pan de Racho, Panque, Tres Leches, Chocoflan, and Pan Surtido

Michigan Firm Recalls Sandwiches For Undeclared Sesame on Buns

Gaws Gourmet Foods of Marysville, MI, is recalling three varieties of 8” deli subs, and two varieties of breakfast bagel sandwiches because they may contain undeclared sesame.  The recall was initiated after it was discovered that the sesame-containing products were distributed in packaging that did not reveal the presence of sesame.  Subsequent investigation indicates the problem was caused by a breakdown in the company's labeling process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gaws-gourmet-foods-issues-allergy-alert-undeclared-sesame-sandwiches
Gaws Gourmet Foods Issues Allergy Alert on Undeclared Sesame in Sandwiches
Summary
Company Announcement Date:  November 30, 2023
FDA Publish Date:  November 30, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame
Company Name:  Gaws Gourmet Foods
Brand Name:  Gaws
Product Description:  Deli sub and breakfast bagel sandwiches

NJ Firm Recalls Dark Chocolate Coin Candy for Undeclared Milk Allergen Due to Mislabeling

Manischewitz, of Bayonne, NJ, is recalling Manischewitz Dark Chocolate Coins because it may contain undeclared milk.  This recall was initiated after the company was notified by their Quantity Control Department that a limited number of bags labeled as “Dark Chocolate Coins” contained Milk Chocolate Coins, which contains milk allergen that is not declared on the label. All dairy Milk Chocolate Coins are wrapped in Gold Foil within a Blue Netting and all non-dairy Dark Chocolate Coins are wrapped in Silver Foil within a Red Netting.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/manischewitz-issues-product-mislabeling-advisory-and-voluntary-recall-some-very-limited-units-their
Manischewitz Issues a Product Mislabeling Advisory and Voluntary Recall on Some Very Limited Units of their Dark Chocolate Coins
Summary
Company Announcement Date:  December 01, 2023
FDA Publish Date:  December 01, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk.
Company Name:  Manischewitz
Brand Name:  Manischewitz
Product Description:  Dark Chocolate Coins

NY Establishment Recalls Various RTE Poultry Products After Positive Listeria Test

Pelleh Poultry Corp., a Swan Lake, N.Y. establishment, is recalling approximately 708 pounds of ready-to-eat (RTE) beef and poultry products that may be adulterated with Listeria monocytogenes.  The RTE beef and poultry products were packaged on various dates from October 25, 2023, through November 20, 2023.  The problem was discovered when the establishment notified FSIS that its laboratory testing indicated the product may be contaminated with Listeria monocytogenes.

https://www.fsis.usda.gov/recalls-alerts/pelleh-poultry-corp--recalls-ready-eat-beef-and-poultry-products-due-possible
Pelleh Poultry Corp. Recalls Ready-To-Eat Beef and Poultry Products Due to Possible Listeria Contamination

WASHINGTON, Dec. 1, 2023 – Pelleh Poultry Corp., a Swan Lake, N.Y. establishment, is recalling approximately 708 pounds of ready-to-eat (RTE) beef and poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FDA Provides Updated Support Documents for Traceability Rule

FDA provided some updated materials to help companies comply to the Food Traceability Final Rule, that goes into effect on January 20, 2026.  The article in Food Safety Magazine has identified the updated material, but the exact updates are not obvious on the FDA webpage.

This only applies to certain foods that have been judged as having certain risks - Cheeses, shell eggs, nut butters, fresh cucumbers, fresh herbs, fresh and fresh cut leafy greens, fresh melons, fresh peppers, fresh spouts, fresh tomatoes, fresh tropical tree fruits, fresh cut fruits, specific fresh and raw frozen finfish, smoked finfish, fresh and frozen crustaceans and mollusks, RTE deli salads,

One useful addition is the Traceability Plan Example for Restaurants (although it is half example, half explanation, so not really a great example) - https://www.fda.gov/media/174058/download?attachment

https://www.food-safety.com/articles/9065-fda-releases-new-resources-for-food-traceability-final-rule-compliance

FDA Releases New Resources for Food Traceability Final Rule Compliance
By Food Safety Magazine Editorial Team

November 30, 2023

The U.S. Food and Drug Administration (FDA) recently rolled out additional tools and answers to frequently asked questions (FAQs) to inform stakeholders about Section 204 of the Food Safety Modernization Act (FSMA 204), also known as the Food Traceability Final Rule, and help aid entities with compliance.

Additional Recalls for Fruit Products Using Recalled Cantaloupes, CDC Provides Case Update

Updated 12/6/23

A number of food processor / distributors are recalling fruit / cantaloupe products that were derived from cantaloupes that are involved in the recent Malachita cantaloupe recall.  In an updated CDC report, there are now 117 cases with 61 hospitalizations and 2 deaths.

• TGD Cuts, LLC has initiated a voluntary recall of the specific fresh-cut fruit cup, clamshell and tray products
• Pacific Trellis Fruit, LLC is initiating a voluntary recall of 4,872 cases of Malichita brand whole cantaloupe
• Cut Fruit Express Inc. of Inver Grove Heights, MN, is recalling Caribou Coffee Fruit Mix CHPG 6.5oz, and Cut Fruit Express Brand of 6.5oz, 15oz, 16oz, 32oz packages of Fruit Mix contains Cantaloupes and Food service packages of 5lb tray, 10lb bag, 25lb Pail,
• Bix Produce of Little Canada, MN., is issuing a voluntary recall of Grab N’ Go containers of cut cantaloupe and mixed fruit cups 
• GHGA, LLC is voluntarily recalling select fresh-cut products made from whole cantaloupe subject to a previously announced product recall initiated by Sofia Produce, LLC dba Trufresh

FDA Provides Update on Lead Contamination Issue in Apple Cinnamon Sauce Product

In the most recent update on the lead poisoning associated with cinnamon apple pouches, FDA states that there as of Nov 30, there are 57 reported cases (there were 34 reported on Nov 16). To date, confirmed complainants are aged less than 1 to 5 years of age. FDA also identified the supplier of the cinnamon, thought to be the source of the lead in the finished product. The product was produced in Ecuador by Austrofood and was distributed by Wanabana USA, the distributor of WanaBana products.  "The cinnamon used to manufacture the recalled products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador."

"The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S."

Adverse Event Overview
Total FDA Adverse Events: 57*
Report Date Ranges: October 17, 2023 – November 28, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2) IA (1), IL (2), KY (3), LA (4), MA (3), MD (4), MI (3), MO (1), NC (5), NE (1), NH (1), NM (1), NY (8), OH (2), PA (1), SC (2), TN (1), TX (3) VA (1), WA (3)
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023
Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.

Current Update
November 30, 2023