Monday, February 27, 2023

USDA Issues Health Alert for Pasta Sauce Labeled as Pizza Sauce

USDA-FSIS is issuing a public health alert due to concerns that fully cooked, ready-to-eat (RTE) pasta sauce labeled as pizza sauce contains anchovies and milk, known allergens, as well as ground beef and sulfites, which are not declared on the product label. The problem was discovered after the firm received a consumer complaint that meat was in the pizza sauce and notified FSIS. The establishment determined that employees labeled a limited number of “Bolognese Pasta Sauce” packages as “Homestyle Pizza Sauce”.

The product was made by Heritage Specialty Foods of Milwaukie, OR.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-new-seasons-pizza-sauce-due-misbranding-and
FSIS Issues Public Health Alert for New Seasons Pizza Sauce Due to Misbranding and Undeclared Allergens

HERITAGE SPECIALTY FOODS, LLC


FSIS Announcement

WASHINGTON, Feb. 23, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that fully cooked, ready-to-eat (RTE) pasta sauce labeled as pizza sauce contains anchovies and milk, known allergens, as well as ground beef and sulfites, which are not declared on the product label. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

Canned Shrimp Recalled after Complaints for Leaking Cans

Kawasho Foods USA Inc. of New York, NY, is voluntarily recalling one lot of canned GEISHA Medium Shrimp 4oz. because of reported swelling, leaking, or bursting cans.  The GEISHA Medium Shrimp is packaged in a 4oz. metal can, with UPC 071140003909. The one lot being recalled is LGC12W12E22; BEST BY: MAY/12/2026 and this code appears on the bottom of the product can.  This could be an underprocessing issue, which then it is a risk for Clostridium botulinum.  Other issues could be improper seaming.  Another issue could be thermophilic spoilage.  As an imported product coming from Thailand or other location, exposure to hot conditions during shipment could result in the growth of thermophilic sporeforming spoilage organisms.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kawasho-foods-usa-inc-announces-voluntary-recall-single-lot-geisha-medium-shrimp-4oz-because
Kawasho Foods USA Inc. Announces a Voluntary Recall of a Single Lot of GEISHA Medium Shrimp 4oz. Because of Possible Health Risk
Summary
Company Announcement Date:  February 26, 2023
FDA Publish Date:  February 26, 2023
Product Type:  Food & Beverages  Shellfish
Reason for Announcement:  Potential contamination with Clostridium botulinum
Company Name:  Kawasho Foods USA, Inc.
Brand Name:  GEISHA
Product Description:  GEISHA Medium Shrimp, 4 oz can

Friday, February 24, 2023

Jars of Labeled as Roasted Red Peppers Recalled for Pine Nuts After Mislabeling Issue

Sunny Dell Foods, LLC. of Oxford, PA, is recalling its 12-ounce jars of "Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms" because the affected jars of the condiment may contain undeclared Trees Nuts (Pine Nuts).  The recall was initiated after it was discovered that a tree nut-containing condiment product was distributed in the Rao’s Homemade Brand Roasted Peppers with Portobello Mushrooms packaging that did not reveal the presence of tree nuts (pine nuts). Subsequent investigation indicates the problem was caused by an accidental mislabeling during the production run.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunny-dell-foods-llc-issues-allergy-alert-undeclared-tree-nuts-pine-nuts-raos-homemade-brand-roasted
Sunny Dell Foods, LLC Issues Allergy Alert on Undeclared Tree Nuts (Pine Nuts) in "Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms"
Summary
Company Announcement Date:  February 21, 2023
FDA Publish Date: February 22, 2023
Product Type: Food & Beverages
Reason for Announcement: Undeclared Pine Nuts
Company Name: Sunny Dell Foods, LLC
Brand Name: Rao’s Homemade
Product Description: Roasted Red Peppers with Portobella Mushroom

WA Company Recalls Cherry Candy Product for Undeclared Hazelnuts

Chukar Cherry Company of Prosser, WA is voluntarily recalling a limited quantity of Cherry Bombs because the product may contain hazelnuts.  No reason was listed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/chukar-cherry-company-prosser-wa-voluntarily-recalling-limited-quantity-cherry-bombs-because-product
Chukar Cherry Company of Prosser, WA is Voluntarily Recalling a Limited Quantity of Cherry Bombs Because the Product May Contain Hazelnuts
Summary
Company Announcement Date: February 21, 2023
FDA Publish Date:  February 21, 2023
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared Hazelnuts
Company Name:  Chukar Cherry
Brand Name:  Chukar Cherry
Product Description: Cherry Bombs

FDA Issues Draft Guidance that Plant-based Non-Milk Product Can Be Called Milk

FDA issued a proposal that says plant-based beverages can be called milk provided they list the plant material from which they were derived.  "The rules also call for voluntary extra nutrition labels that note when the drinks have lower levels of nutrients than dairy milk, such as calcium, magnesium or vitamin D. They would continue to allow labels that note when plant-based drinks have higher levels. Fortified soy milk is the only plant-based food included in the dairy category of U.S. dietary guidelines because of its nutrient levels."

AP News
https://apnews.com/article/us-food-and-drug-administration-business-health-nutrition-ed2acef14a014eef30a0fd24f98be07b
No cow needed: Oat and soy can be called milk, FDA proposes

Australia - Case of Botulism Linked to Almond Milk

In Australia, temperature abused almond milk was linked to a botulism case.

https://www.abc.net.au/news/2023-02-16/almond-milk-recalled-in-nsw-over-botulism-fears/101985952
Almond milk recalled in NSW after link to botulism poisoning

Posted Thu 16 Feb 2023 at 12:57amThursday 16 Feb 2023 at 12:57am, updated Thu 16 Feb 2023 at 1:37am

A brand of almond milk is being recalled in NSW after it was linked to a case of potentially life-threatening botulism.

Wednesday, February 22, 2023

Canada - French Wine Recalled for Presence of Glass Pieces

The CFIA issued a recall for Louis Latour brand Pinot Noir (2021) in the 375ml bottle due to foreign material in the form of glass.  For wine in glass, producers need to consider glass shards are a potential hazard.  This often occurs in the bottling process as the filler nozzle enters the top of the bottle or during capping / corking.

https://recalls-rappels.canada.ca/en/alert-recall/louis-latour-brand-pinot-noir-recalled-due-possible-presence-glass
Louis Latour brand Pinot Noir recalled due to possible presence of glass

Brand(s) Louis Latour  Pinot Noir Bourgogne 2021  375 mL
Last updated  2023-02-18

USDA Issues Health Alert RTE Breakfast Bowls After Distributor Temperature Abuses Product

U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that not-ready-to-eat meat products - breakfast bowls - that were subject to temperature abuse during storage at a distribution center prior to delivery to retailers, which may have resulted in the growth of spoilage organisms or pathogens.  The problem was discovered when the producing establishment notified FSIS that their customer reported storing the product in an unrefrigerated area. FSIS found that the product was held at an incorrect temperature and then shipped into commerce. All remaining inventory of the affected items have been removed from the stores and destroyed.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-frozen-not-ready-eat-signature-select-breakfast-bowl
FSIS Issues Public Health Alert for Frozen, Not-Ready-To-Eat Signature Select Breakfast Bowl Products Due to Possible Temperature Abuse at Distribution Center

FSIS Announcement

WASHINGTON, Feb. 15, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that not-ready-to-eat meat products were subject to temperature abuse during storage at a distribution center prior to delivery to retailers, which may have resulted in the growth of spoilage organisms or pathogens. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

USDA Health Alert for RTE Chicken Entrée with Undeclared Soy and Milk Allergens

USDA-FSIS issued a public health alert due to concerns that the raw, ready-to-cook chicken entrĂ©e products may be missing labeling that includes the list of ingredients and cooking instructions. This product contains soy and milk, known allergens, which may not be declared on the finished product label.  A recall was not requested because the products are no longer available for purchase.  The problem was discovered when the establishment notified FSIS that the product was inadvertently misbranded when a printer did not place the bottom label on the product packaging. As a result, the list of ingredients and the cooking instructions are missing.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-raw-ready-cook-stuffed-chicken-products-due
FSIS Issues Public Health Alert for Raw, Ready-To-Cook Stuffed Chicken Products Due to Misbranding and Undeclared Allergens

TAMPA BAY FISHERIES

FSIS Announcement

WASHINGTON, Feb. 14, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that the raw, ready-to-cook chicken entrĂ©e products may be missing labeling that includes the list of ingredients and cooking instructions. This product contains soy and milk, known allergens, which may not be declared on the finished product label. FSIS is issuing this public health alert to ensure that consumers with an allergy to soy and dairy are aware that these products should not be consumed and to ensure that consumers properly cook this product to an internal temperature of 165 degrees as measured by a food thermometer. A recall was not requested because the products are no longer available for purchase.

NY Establishment Recalls Pasta Product After Formulation Changes Adds Undeclared Egg

Whitson’s Food Service (Bronx) Corp., an Islandia, N.Y., establishment, is recalling approximately 8,713 pounds of frozen, ready-to-cook chicken alfredo with broccoli and penne pasta meals due to misbranding and undeclared allergens, in this case, the product contains egg, a known allergen, which is not declared on the product label.  The problem was discovered when the producing establishment received a consumer complaint and notified FSIS. The establishment investigated and determined that they updated the product formulation with a sauce containing egg, but the information was not provided to the nutrition department that creates the product labels. As a result, the immediate product labels do not list egg as an allergen and the case labels do not list egg in the ingredient statement.

https://www.fsis.usda.gov/recalls-alerts/whitsons-food-service-bronx-corp--recalls-frozen-ready-cook-chicken-alfredo-broccoli
Whitson’s Food Service (Bronx) Corp. Recalls Frozen, Ready-To-Cook Chicken Alfredo with Broccoli and Penne Pasta Products Due to Misbranding and Undeclared Allergens.

Food Importers Cited for Not Having FSVP - Jan-Feb 2023 Edition

FDA issued Warning Letter to the following food importers for not having a FSVP in place for their imported foods.

Sohgave LLC of Houston, TX did not develop, maintain, and follow an FSVP for any imported foods including Honey from one foreign company and Agave Syrup, honey, coconut syrup and inulin syrup imported from another.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sohgave-llc-646874-01192023

AMO and Wing Inc. dba T and H Trading Co. of Oakland, CA - as "a very small importer is must obtain written assurance, in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act. Specifically, you did not provide written assurances from your foreign suppliers for any of the foods you import, including dried noodle and dried bean curd from (b)(4); and vermicelli from (b)(4)."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amo-and-wing-inc-dba-t-and-h-trading-co-638293-12072022

HST Produce, Inc. of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, the firm did not develop, maintain, and follow an FSVP for any of their imported foods including each of the following foods:
Fresh prickly pear imported from (b)(4), Fresh jalapeno pepper imported from (b)(4), Peruano beans imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hst-produce-inc-639794-11072022

S&S Quality Wholesale Inc. of El Cajon, CA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). for any of thier imported foods including:  Bashan Koftelik Bulgur Fine imported from (b)(4), located in (b)(4), Bread Sticks imported from (b)(4), located in (b)(4),Wheat Kernal Habiya imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ss-quality-wholesale-inc-630772-06012022

Leimax, Corp of Yonkers, NY did not develop an FSVP for any of the their imported foods including each of the following foods: Lollipops ((b)(4)) manufactured by (b)(4). Cola flavored soft drink manufactured by (b)(4). (b)(4) hot sauce manufactured by (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/leimax-corp-633364-10072022

Fuentes Farms LLC of McAllen, TX 7 did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).for any of their imported foods including: green onions imported from foreign supplier (b)(4) chayote imported from foreign supplier (b)(4)
broccoli imported from foreign supplier (b)(4)

"You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112)."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fuentes-farms-llc-642138-10142022

TL State Management of Brooklyn, NY did not develop an FSVP for any of their imported  food products including Pickled red tomatoes from (b)(4)  Puff pastry dough from (b)(4) and (b)(4) wafers from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tl-state-management-inc-634663-08302022

San-Rey Produce Inc.of Pharr, Texas. did not develop an FSVP for any of their imported foods including:  onions imported from foreign supplier, (b)(4), (b)(4) limes imported from foreign supplier, (b)(4) and coriander imported from foreign supplier,
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/san-rey-produce-inc-643593-12072022

FDA Issues a Warning Letter to Processor of Aseptic Nutritional Beverages for Inadequate Handling of Process Deviations

FDA issued a Warning Letter to Lyons Magnus, a CA company with a Wisconsin based processing operation for aseptically packaged nutritional beverages. The inspection was conducted in response to a recall that occurred in July of 2022 due to an under-processing issue of the low acid product that had the potential to allow pathogens such as Clostridium botulinum survive.

The issue that caused the recall was when the company identified gram positive rods in the product....but this was not the first time the company found organisms in the finished product. FDA states "Your notification to FDA occurred (b)(4) after your positive lab tests for gram-positive rods on (b)(4), and (b)(4) after lab testing confirmed the Bacillus subtilis result. Moreover, our review of your micro testing records dating back to (b)(4), noted your internal microbiological tests indicated gram-positive, gram-negative rods, and cocci in approximately 37 batches of finished products which were released and shipped. These test results demonstrate the presence of viable microorganisms in your commercial products, the majority of which you had not previously reported to FDA. "

FDA goes on to state, "We remind you that your aseptically packaged products containing viable microorganisms do not meet the definition of commercial sterility, per 21 CFR 113.3(e)(1)(i)(a) and are, therefore, adulterated. Shipping adulterated products into interstate commerce is a prohibited act under section 301(a) of the Act. Under 21 CFR 108.35(e) your firm must promptly alert FDA of lots shipped with known microbial contamination, not just those lots with confirmed species as identified in July 2022. Additionally, you shipped these products without conducting a full investigation into the cause of the microbial contamination. You indicated in your October 5, 2022, response that micro findings prior to April 2022 were attributed to laboratory error, yet you did not conduct an assessment of your laboratory practices prior to April 2022. Microbial findings in finished product indicate a loss of sterility during production of that batch and warrant further investigation. Per 21 CFR 113.40(g)(2)(ii)(B), “[i]n the event of loss of sterility, the system(s) shall be returned to a condition of commercial sterility before resuming packaging operations.”

It seems that much of the issue resulted when the company completed a process change that increased the volume run through the processor.  And although the company recognized a microbial contamination issue, they continued to run the modified process.  There were also indicators with the cleaning process was not effective.  There were some additional comments regarding their handling of process deviations.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lyons-magnus-llc-645766-01302023
WARNING LETTER
Lyons Magnus, LLC

MARCS-CMS 645766 — JANUARY 30, 2023
Recipient:
Edward Carolan
Chief Executive OfficerLyons Magnus, LLC

Tuesday, February 21, 2023

FDA Issues Warning Letter to Cruise Line for Not Maintaining Safe Water Supply

FDA inspected American Cruise Line's American Star and American Heritage vessels from in April 2022, through June 2022, and from June 2022, through August 2022. The investigation and inspections were initiated by FDA after three passengers who traveled in April 2021, September 2021, and September-October 2021 aboard these vessels were diagnosed with Legionnaires’ disease. FDA investigators collected biofilm swabs and potable water samples from these vessels and identified Legionella pneumophilia serogroup 1 and Legionella spp. in the potable water system of the vessels thus determine that the water is adulterated as defined by regulation..

FDA had issues with the response by the company in terms of response to the issue. There were issues with the test methodology the company was using..The company did "not monitor potable water parameters, such as free or total chlorine residual, temperature, and pH on the vessel when docked and not in operation or while in operation."

ProSobee Simply Plant-Based Infant Formula Due to Possibility of Cross-contamination with Cronobacter sakazakii

Reckitt, a producer of nutrition products, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two (2) select batches of ProSobee 12.9 oz. Simply Plant-Based Infant Formula due to a possibility of cross-contamination with Cronobacter sakazakii. All product distributed went through extensive testing and tested negative for the bacteria.
 
According to the report, "The batches in question tested negative for Cronobacter and other bacteria and this is an isolated situation. After a thorough investigation, we have identified the root cause, which was linked to a material from a third party. We have taken all appropriate corrective actions, including no longer sourcing this material from the supplier."


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckitt-recalls-two-batches-prosobee-129-oz-simply-plant-based-infant-formula-because-possible
Reckitt Recalls Two Batches of Prosobee 12.9 oz Simply Plant Based Infant Formula Because of Possible Health Risk
Summary
Company Announcement Date:  February 20, 2023
FDA Publish Date:  February 20, 2023
Product Type:  Food & Beverages  Infant Formula & Foods
Reason for Announcement:   Potential Cronobacter sakazakii contamination
Company Name:  Reckitt
Brand Name:  Enfamil ProSobee
Product Description:  Enfamil Prosobee Simply Plant-Based Infant Formula in 12.9 oz containers

More Enoki Mushrooms Recalled for Listeria After MD State Lab Finds Positive Sample

Xin Ao International Group Corp of Linden, NJ, is recalling its 200 grams packages of “Sss Enoki Mushroom” and “K-Fresh Mushroom”, because it has the potential to be contaminated with Listeria monocytogenes.  The recall was the result of a routine sampling program by Maryland Department of Health which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/xin-ao-international-group-corp-recalls-sss-enoki-mushroom-k-fresh-mushroom-because-potential-health
Xin Ao International Group Corp. Recalls "Sss Enoki Mushroom" & “K-Fresh Mushroom” Because of Potential Health Risk
Summary
Company Announcement Date:  February 17, 2023
FDA Publish Date:  February 17, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Xin Ao International Group Corp.
Brand Name:  Xin Ao International Group Corp.
Product Description:  Enoki Mushrooms

Saturday, February 18, 2023

Valentine Candy Recalled for Undeclared Tree Nuts

Silvestri Sweets Inc. of Geneva, IL is voluntarily recalling its 8 ounce bags of Favorite Day branded Valentine’s Milk Chocolate Covered Caramels with Nonpareils because they may contain an undeclared tree nut.   The recall was initiated after it was discovered that possible tree nut inclusions were distributed in packaging and/or product that did not reveal the presence of tree nuts. Subsequent investigation indicates the problem may have been caused by a temporary breakdown in the company’s production and packaging process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/silvestri-sweets-issues-voluntary-allergy-alert-undeclared-pecan-milk-chocolate-caramels
Silvestri Sweets Issues Voluntary Allergy Alert on Undeclared Pecan in Milk Chocolate Caramels
Summary
Company Announcement Date: February 14, 2023
FDA Publish Date:  February 16, 2023
Product Type:  Food & Beverages  Snack Food Item  
Reason for Announcement:  Undeclared pecan allergen
Company Name:  Silvestri Sweets Inc.
Brand Name:  Favorite Day
Product Description:  Milk Chocolate Covered Caramels with Nonpareils

Asian Spice Mix Recalled for Undeclared Sesame After Mislabeling Incident

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is recalling 10.58 oz packages of Shirakiku brand Spice Seasoning products (Spice Ichimi Togarashi 300g and Spice Shichimi Togarashi 300g). The product package of Ichimi spice seasoning contains Shichimi spice seasoning contents (incorrect package) causing the undeclared allergen of sesame seeds. The outer carton of “Ichimi” and “Shichimi” may possibly contains inner packages of “Ichimi”, and the inner packages contain “Shichimi” contents. The recall was initiated after it was discovered that the product containing sesame was distributed in packaging that did not reveal the presence of sesame. Subsequent investigation indicates the problem was caused by a human error during the packing process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wismettac-asian-foods-issues-allergy-alert-undeclared-spice-seasoning
Wismettac Asian Foods Issues Allergy Alert on Undeclared Spice Seasoning
Summary
Company Announcement Date:  February 14, 2023
FDA Publish Date:  February 14, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame
Company Name:  Wismettac Asian Foods, Inc.
Brand Name:  Shirakiku
Product Description:  Ichimi spice powder, 10.58 oz

CA Distributor Pulls More Imported Snack Products for Lack of Allergen Labeling

Daiso California LLC of La Mirada, CA is recalling even more snack products that lack proper allergen labeling.  This company has issued other recalls over the past few months for the same issue....lack of allergen labeling on imported snack products.  The last posted recall was issue on February 3, 2023.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-prepackaged-snacks-0
Daiso Issues Allergy Alert for Prepackaged Snacks
Summary
Company Announcement Date: February 13, 2023
FDA Publish Date:  February 13, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk, wheat, soy, tree nuts
Company Name:  Daiso California, LLC
Brand Name:  Various
Product Description:   Various Snack Foods

Thursday, February 9, 2023

Health Alert issued for A CA Establishment's Sausage Product Due to Undeclared Allergens

USDA is issuing a public health alert due to concerns that the ready-to-eat (RTE) pork sausage link products made by GOULART'S SAUSAGE CO of San Jose CA.  The product may contain milk, a known allergen, which is not declared on the finished product label.  The problem was discovered during routine inspection activities when FSIS observed the establishment adding nonfat dry milk to an ingredient in the Linguica links products. The finished product labels for these Linguica links products do not identify nonfat dry milk as an ingredient and do not declare milk as an allergen.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-pork-sausage-products-due-misbranding-and
FSIS Issues Public Health Alert for Ready-To-Eat Pork Sausage Products Due to Misbranding and an Undeclared Allergen

GOULART'S SAUSAGE CO.

WASHINGTON, Feb. 8, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that the ready-to-eat (RTE) pork sausage link products may contain milk, a known allergen, which is not declared on the finished product label. FSIS is issuing this public health alert to ensure that consumers with an allergy to dairy are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

Prescription Pet Food Recalled for Elevated Levels of Vitamin D

NestlĂ© Purina PetCare Company is voluntarily recalling select lots of Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food due to potentially elevated levels of vitamin D.  Ingestion of elevated levels can lead to health issues, depending on the level of vitamin D and the length of exposure, can include vomiting, loss of appetite, increased thirst, increased urination, and excessive drooling to renal (kidney) dysfunction.  Purina is taking this action after receiving two contacts about two separate confirmed cases of a dog exhibiting signs of vitamin D toxicity after consuming the diet, to date. Once taken off the diet, each of these dogs recovered.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-purina-petcare-company-voluntarily-recalls-purina-pro-plan-veterinary-diets-el-elemental-dry
Nestlé Purina Petcare Company Voluntarily Recalls Purina Pro Plan Veterinary Diets El Elemental Dry Dog Food in the U.S. Due to Potentially Elevated Vitamin D
Summary
Company Announcement Date:  February 08, 2023
FDA Publish Date:  February 08, 2023
Product Type:  Animal & Veterinary  Food & Beverages 
Reason for Announcement:  Potentially elevated Vitamin D
Company Name:  Nestle Purina PetCare Company
Brand Name:  Purina
Product Description:  Veterinary Diets EL Elemental Dry Dog Food

OR Company Recalls Snack Products for Incorrect Allergen Labeling

Pilgrim’s Roasted Nut’Z of North Plains, Oregon is recalling following products due to undeclared milk, soy, and/or walnut.   The products are packaged in either 8 oz plastic cone bags or 8 oz pouch bags with no lot code or best by date. The products were sold in retail stores in Oregon, Washington and California and through the company’s website (https://pilgrimsroastednutz.com/External Link Disclaimer) and farmers markets and events in Oregon.
Looks like someone didn't read any of the regulations, but guessed what was to go on the label.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pilgrims-roasted-nutz-issues-allergy-alert-undeclared-milk-soy-walnut-snack-products
Pilgrim’s Roasted Nut’z Issues Allergy Alert on Undeclared Milk, Soy, Walnut in Snack Products
Summary
Company Announcement Date:  February 06, 2023
FDA Publish Date:  February 08, 2023
Product Type:  Food & Beverages  Nuts & Nut Products
Reason for Announcement:  Undeclared milk, soy, walnut
Company Name:  Pilgrim’s Roasted Nut’ Z
Brand Name:  Pilgrim’s Roasted Nut’ Z
Product Description:  Chocolate Toffee Almonds, Crème Brulee Cashews, Tri-Color Chocolate Expresso Bean, more

Imported Cake Product Recalled for Undeclared Eggs

Titans Global Inc. of City of Industry, CA, is recalling its 95g packages of “JSJ Chocolate Cake", “JSJ ZSR Cake”, “JSJ DMC Leaf Cake” food treats because they may contain undeclared eggs.  Product is imported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/titans-global-inc-issues-allergy-alert-undeclared-egg-jsj-chocolate-cake-jsj-zsr-cake-jsj-dmc-leaf
Titans Global Inc Issues Allergy Alert on Undeclared Egg in “JSJ Chocolate Cake”, “JSJ Zsr Cake”, “JSJ DMC Leaf Cake”
Summary
Company Announcement Date:  February 06, 2023
FDA Publish Date:  February 06, 2023
Product Type:  Food & Beverages
Reason for Announcement:  undeclared egg
Company Name:  Titans Global Inc
Brand Name:  JSJ
Product Description:  Cake

Wednesday, February 8, 2023

Warning Letter Issued for Salmonella Outbreak Linked to Peanut Butter - A Case Study for Testing for Safety in Light of Resident Contamination

FDA issued a Warning Letter to Smucker after conducting an inspection in their Lexington, KY facility after product from that facility was linked to a Salmonella outbreak.40505-3728 from May 19, 2022, through June 9, 2022.  The recall was published on May 21, 2022.  CDC reports that 21 people from 17 states fell ill from the product.

Inspectors found "found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation" and "failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule"

I tried to summarize this in a way to better focus on the issues.  One primary point is that if there is a issue, using testing to resolve did not work.
  • Through WGS (whole genome sequencing, "FDA identified five recent 2022 clinical isolates (samples collected from ill people) which matched over one hundred third-party peanut butter and environmental isolates from Kentucky collected from 2014 to 2017."  "The presence of the same S. Senftenberg strain in [the] facility since 2010, which matched the clinical cluster, is indicative of a resident strain. "
  • The company's "finished product testing records from January 1, 2021, to February 23, 2022, indicate that [the company] detected Salmonella in .... RTE peanut butter on numerous occasions, i.e., October 22 and December 15, 2021; and February 4, 9, 10, 20, and 21, 2022, and that [the company's] corrective actions were not sufficient to address the root cause of the contamination.
  • The issue - 'the establishment identified a leak in the air intake vent of the cooling chamber of Roaster as a source of water entering the equipment and that was repaired, however within a few days  after the repair was completed, Salmonella was detected.  Subsequently, additional samples were tested  from the lot[s] produced immediately prior to and after the product that tested positive.  testing found that that initially, lots tested negative for Salmonella but then identified two additional positive lots. The next day, Salmonella was detected  in a lot. Similar to February 20, after testing  lots that initially tested negative for Salmonella, additional lots tested positive.'
  • The company indicated that when the additional samples test negative, they destroy all  production lots to provide further assurance we have bracketed and eliminated any potential contamination.” "However, the positive test results for lots for which Salmonella was previously not detected show the limitations of reliance on [the]testing program to identify contamination as a way to prevent contaminated products from reaching consumers. Further, the S. Senftenberg outbreak shows that neither [the company's] corrective actions nor finished product testing was adequate to prevent contaminated product from reaching consumers and causing illnesses."
  • The company responded on July 1, 2022 that they  updated the finished product testing procedures to include a “Hold” procedure in the event a single positive result that is detected in RTE peanut butter where lots will be held ” produced (b)(4) hours before and (b)(4) hours after the affected (i.e., positive) lot and performing further testing using (b)(4) samples from only the (b)(4) lots on “each extreme of the bracketed window” (i.e., only the (b)(4) or (b)(4) lot on either end of the held product).   The concern from FDA's letter is that this approach in response to a contamination event would not ensure all affected product would be identified and prevented from entering commerce. [FDA] is not aware of any data or scientific rationale to support how your (b)(4) Hold would be an effective approach to identify all product affected by a contamination event in your continuous production of RTE peanut butter. 
So basically, you cannot test your way to safety.  Salmonella should not be in that product period.  And if product is positive, testing to determine what is safe is a gamble and there are bigger issues that have to be solved.   In this case, tearing it all down and figuring out how it got there and then correcting the problem is the preventive approach.

Another interesting item was that the company did not identify Salmonella as a hazard in the post-process enviroment.  From the report, the company " did not consider the hazard of recontamination with environmental pathogens, such as Salmonella spp., at post-roasting processing steps from blanching to sorting and milling (including (b)(4)). In-process RTE peanuts are exposed to the environment at these steps, and the food does not receive further treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."

There was a knock on the corrective action procedures in that Salmonella contamination was still being found -  The " environmental monitoring records from 2021 revealed five Salmonella positive environmental swabs in your facility on July 6, July 8, July 12, September 3, and November 16, 2021. These Salmonella positive swabs were found on the floors near your blanch nut tank rooms, roaster booth (b)(4), the stairs at the top level of the nut house (b)(4), and the stairs leading to platform “(b)(4)”. The detection of Salmonella in your facility in 5 locations in 2021, many of which were similar to locations where you detected Salmonella in 2018 and 2019, show that your corrective action procedures in response to environmental contamination in 2018 and 2019 were not sufficient to reduce the likelihood that environmental contamination would recur, as required by 21 CFR 117.150(a)(2)(ii)."

FDA finishes the report stating the concern that Salmonella may be a resident contaminate within the facility and that broader measures are needed.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jm-smucker-llc-638042-01242023
J.M. Smucker LLC
MARCS-CMS 638042 — JANUARY 24, 2023

Monday, February 6, 2023

Cereal Producer Pleads Guilty in 2018 Salmonella Outbreak for Failing to Correct Contamination Issue

 From an article in Food Safety News, the producer of Honey Smacks cereal, Kerry Inc, pleaded guilty to operating a food facility in unsanitary conditions that lead to product becoming contaminated with Salmonella.  The plea agreement will include a $19.2 million payout.

In this outbreak, at least 135 people reported being ill with 34 people hospitalized.

"Documents unsealed today revealed that Salmonella had been found on an ongoing basis at the Kerry manufacturing plant in Gridley, IL. During the time period June 2016 to June 2018, routine environmental tests detected Salmonella in the plant 81 times, including at least one positive Salmonella sample each month.  According to the plea agreement with the company, employees at the Gridley facility routinely failed to implement corrective and preventative actions to address positive Salmonella tests."

"In a related case, Ravi K. Chermala, Kerry’s Director of Quality Assurance until September 2018, previously pleaded guilty to three federal misdemeanor counts of causing the introduction of adulterated food into interstate commerce. Chermala oversaw the sanitation programs at various Kerry manufacturing plants, including the Gridley facility.  “In pleading guilty, Chermala admitted that between June 2016 and June 2018, he directed subordinates not to report certain information to Kellogg’s about conditions at the Gridley facility,” according to the Justice Department.  “In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions. Chermala is scheduled to be sentenced on Feb. 16.”"

Source - https://www.foodsafetynews.com/2023/02/largest-food-safety-settlement-entered-in-federal-case-against-honey-smacks/


NC Establishment Recalls RTE Stuffed Chicken Product Due to Potential Undercooking

USDA-FSIS is issuing a public health alert for ready-to-eat (RTE) stuffed chicken product because the product may not be fully cooked due to underprocessing. The RTE broccoli stuffed chicken breast product was produced by Vanguard Culinary Group, LTD, a Fayetteville, N.C. establishment, on December 3, 2022 and was distributed through ALDI. The problem was discovered when consumers reported to FSIS that the product labeled as fully cooked appeared to be raw. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

This product is sold as a fully cooked item, so with heat-and-serve instructions, there may not be sufficient heat to kill any pathogens present on the undercooked chicken.




https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-stuffed-chicken-product-may-be-undercooked
FSIS Issues Public Health Alert for Ready-To-Eat Stuffed Chicken Product that May Be Undercooked Due to A Processing Deviation

VANGUARD CULINARY GROUP, LTD.

FSIS Announcement

WASHINGTON, February 3, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) stuffed chicken product because the product may not be fully cooked due to underprocessing. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for consumers to purchase.

CA Company Posts Another Recall for Missing Allergens on Packaging

Daiso California LLC of La Mirada, CA is recalling the below listed snacks due of undeclared allergen ingredients.  The recall was initiated after it was discovered that packaging did not adequately disclose the presence of all allergens. Sale of the products have been suspended, and Daiso California has pulled the products from store shelves.

See company's recall notice posted on 1/30/23.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-alergy-alert-prepackaged-snacks
Daiso Issues Alergy Alert for Prepackaged Snacks
Summary
Company Announcement Date:  February 03, 2023
FDA Publish Date:  February 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Daiso California LLC
Brand Name:  Daiso California LLC
Product Description:  Powdered apple tea, crackers, cookies & candy

MD Firm Recalled Prepackaged Sandwich and Snack Items After Finding Listeria Positive Environmental Samples

Fresh Ideation Food Group LLC of Baltimore, MD is recalling products sold from January 24, 2023 through January 30, 2023 because the products have the potential to be contaminated with Listeria monocytogenes.    The recall was initiated after the company’s environmental samples tested positive for Listeria monocytogenes.

The products include sandwiches, salads, snacks, yogurt, wraps and related product and were distributed in Connecticut, District of Columbia, Maryland, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, and Virginia. Recalled Products were sold in retail locations, vending machines, and during travel with transportation providers.  Brands include Bistro to Go, Quick and Fresh, Westin, Fresh Creative Cusine, InReach, Orchard Bistro, Naval Academy, Deitz & Watson, and Shaw's.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-ideation-food-group-llc-recalls-sandwiches-and-other-products-because-possible-health-risk
Fresh Ideation Food Group LLC Recalls Sandwiches and Other Products Because of Possible Health Risk
Summary
Company Announcement Date:  February 03, 2023
FDA Publish Date:  February 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria Monocytogenes contamination
Company Name:  Fresh Ideation Food Group
Brand Name:  Multiple brands
Product Description:  Ready to Eat Sandwiches, Salads, Yogurt, Wraps and related products

Frozen Chicken Meal Product Recalled After Customer Finds Different Product in Labeled Package

USDA-FSIS is issuing a public health alert for frozen chicken products due to misbranding and an undeclared allergen. The product contains cashews, a known allergen, which is not declared on the product label.   The frozen products are labeled as Chicken Korma with Basmati Turmeric Rice but may contain Vegetable Tikka Masala with Turmeric Rice.   The problem was discovered when the producing establishment notified FSIS that they received consumer complaints reporting that product labeled as chicken korma actually contained vegetable tikka masala. The vegetable tikka masala contains cashews not declared on the chicken korma product label.

Cafe Spice is the responsible co-packing operation located in New Windsor NY.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-frozen-chicken-korma-basmati-turmeric-rice-products
FSIS Issues Public Health Alert for Frozen Chicken Korma with Basmati Turmeric Rice Products Due to Misbranding and An Undeclared Allergen

CAFE SPICE LLC

FSIS Announcement

WASHINGTON, Feb. 3, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen chicken products due to misbranding and an undeclared allergen. The product contains cashews, a known allergen, which is not declared on the product label. FSIS is issuing this public health alert to ensure that consumers with allergies to cashews are aware that these products should not be consumed. A recall was not requested because it is believed that the products are no longer available for consumers to purchase.

Health Alert Issued for Meat Snack Board for Undeclared Peanut Allergen In Chocolate Wafers

USDA - FSIS is issuing a public health alert for ready-to-eat (RTE) meat snack products containing Food and Drug Administration (FDA) regulated chocolate wafers that have been recalled due to an undeclared allergen, specifically peanut residue.  The problem was discovered when the producing establishment was notified by their wafer supplier that the chocolate wafers are being recalled because they may contain peanut residue, a known allergen, which is not declared on the label. The Canadian Food Inspection Agency (CFIA) notified FSIS that the recalled wafers were used in products distributed to the United States.  The chocolate wafers were used as part of a snack board's food items.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-meat-snack-products-containing-fda
FSIS Issues Public Health Alert for Ready-To-Eat Meat Snack Products Containing FDA-Regulated Wafers that Have Been Recalled Due to Misbranding and an Undeclared Allergen

FSIS Announcement

WASHINGTON, Feb. 1, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ready-to-eat (RTE) meat snack products containing Food and Drug Administration (FDA) regulated chocolate wafers that have been recalled due to an undeclared allergen, specifically peanut residue. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed.

Fudge Cookies Recalled Due to Undeclared Peanut Allergen Due to Supplier Issue

B&G Foods announced today it is voluntarily recalling three cases (18 individual boxes) of a single date code of 6.4 oz. Back to Nature Fudge Mint Cookies, with a “best by” date of OCT 02 2023, after being notified that an ingredient supplied by a third-party ingredient supplier was contaminated with peanut, an allergen not declared on the cookie box label. 

Another supplier-related issue...perhaps the same supplier involved in the recent hot chocolate recalls?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bg-foods-issues-voluntary-allergy-alert-undeclared-peanut-three-cases-back-naturer-fudge-mint
B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies
Summary
Company Announcement Date:  February 01, 2023
FDA Publish Date:  February 01, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  B & G Foods, Inc.
Brand Name:  Back to Nature
Product Description:  Fudge Mint Cookies
Company Announcement  

Another Recall for Undeclared Peanut Allergens in Peanut Butter Hot Chocolate

Two Rivers Coffee of South Plainfield, NJ is voluntarily recalling its peanut butter single serve hot chocolate pods distributed as "Brooklyn Bean Peanut Butter Cup Hot Cocoa", "Pingo Peanut Butter Cookie Hot Chocolate" and “Cold Stone Peanut Butter Cup Perfection” in 12 count, 40count, and 100 count boxes produced from January 2021 to November 2022, due to an undeclared peanut allergen in an ingredient from Two Rivers Coffee’s raw material supplier that was not disclosed to Two Rivers Coffee or its licensors.

This may be the same supplier that had peanut allergen issues that resulted in a similar recall last month.  (Jan 2023).  

It is always a good idea to track recalls and to investigate issues in your own facility when there are recalls related to what you do.

Two Rivers Coffee Issues Allergy Alert on Undeclared Peanut Allergen in Peanut Butter Hot Chocolate
Summary
Company Announcement Date:  January 30, 2023
FDA Publish Date:  January 31, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Two Rivers Coffee
Brand Name:  Brooklyn Bean
Product Description:  3 Flavors of Peanut Butter and/or Hot Cocoa Pods

Imported Biscuits Recalled for Allergen Missing on Label - A Company's Fourth Recall for the Same Issues

Daiso California LLC of La Mirada, CA is recalling the below Matsunaga Mini Shiruko Sand Biscuits (sku 4902773016966) due of undeclared soy ingredients.  The recall was initiated after it was discovered that the product was distributed in packaging that did not correctly warn for the presence of a soy allergen. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging process.

This is the fourth allergen-related recall for this company (Oct 2022, Jan 2023, Jan 2023-2).  All are pretty much the same - importing product with missing allergen labeling.  They better be working on establishing a more robust label review process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-undeclared-soy-matsunga-mini-shiruko-sand-biscuits
Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits
Summary
Company Announcement Date:  January 30, 2023
FDA Publish Date:  January 30, 2023
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared Soy
Company Name:  Daiso California LLC
Brand Name:  Matsunaga
Product Description:  Matsunaga Mini Shiruko Sand Biscuits

Canned Meat Products Recalled for Packaging Defect that Leads to Leakage

Conagra Brands, Inc., a Fort Madison, Iowa establishment, is recalling approximately 2,581,816 pounds of canned meat and poultry products due to a packaging defect that may cause the products to become contaminated without showing any outward signs of contamination.  The problem was discovered when the establishment notified FSIS after observing spoiled and/or leaking cans from multiple production dates at the establishment’s warehouse.  Subsequent investigation by the establishment determined that the cans subject to recall may have been damaged in a manner that is not readily apparent to consumers, which may allow foodborne pathogens to enter the cans.  There have been no confirmed reports of adverse reactions due to consumption of these products.

Leakage issues can result in more significant health problems if organisms like Clostridium botulinum get into the can.


https://www.fsis.usda.gov/recalls-alerts/conagra-brands-recalls-canned-meat-and-poultry-products-due-possible-packaging
Conagra Brands Recalls Canned Meat and Poultry Products Due to Possible Packaging Defect

CONAGRA BRANDS, INC.

FSIS Announcement

WASHINGTON, Jan. 31, 2023 – Conagra Brands, Inc., a Fort Madison, Iowa establishment, is recalling approximately 2,581,816 pounds of canned meat and poultry products due to a packaging defect that may cause the products to become contaminated without showing any outward signs of contamination, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.