FDA and CDC Provide Update on Listeria Outbreak Linked to Supplement Shakes

FDA and CDC provided an update on the investigation of Listeria in frozen shakes.

As of February 24, 2025, a total of 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states.   There have been 12 deaths, up one from the initial report.  Of the 38 people for whom information is available, 37 people have been hospitalized, and 12 deaths have been reported.  Age Range -  from 43 to 101 years with a median age of 78.

Case Counts

Total Illnesses: 38

Hospitalizations: 37

Deaths: 12

Last Specimen Collection Date: January 23, 2025

States with Cases: AL, CA, CO, CT, FL, IL, IN, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WA, and WV

Product Distribution: Nationwide

As summarized by CIDRAP

• Starting in 2018, illnesses were reported but at that time, epidemiologic investigations suggested that institutional food was the likely source, however there wasn't enough evidence to pinpoint a specific food source.
• There were subsequent investigation in 2021, and 2023, in addition to 2018.
• The CDC reopened the investigation in October 2024 after six new infections were reported. In background information on the outbreak, the Food and Drug Administration (FDA) said 20 of the cases were reported in 2024 and 2025 and that the outbreak and the investigations are ongoing.
• In November 2024, the FDA focused on nursing homes where many of the cases occurred. In its investigation, FDA used food invoices from involved nursing homes to show that since 2024, all nursing homes had received frozen supplement shakes from Lyons ReadyCare or Sysco Imperial brand.
• FDA investigators used environmental sampling and whole-genome sequencing to show that the strain of Listeria found in environmental samples were closely related to isolates from sick patients.  "Three of the environmental swabs collected from the processing area tested positive for Listeria monocytogenes. Whole Genome Sequencing analysis determined that the Listeria detected in these samples is closely related to the strain of Listeria that is causing illnesses in this outbreak."
• On February 22, Lyons Magnus, a distributor based in Fresno, California, recalled 4-ounce servings of several flavors of Lyons ReadyCare and Sysco Imperial Frozen supplemental shakes.

Washington State Firm Recalls RTE Chicken Caesar Wraps Due to Undeclared Anchovies (Fish)

LPK1, a Renton, Wash. establishment, is recalling approximately 303 pounds of ready-to-eat chicken Caesar wrap products due to misbranding and an undeclared allergen - the product’s individually-wrapped Caesar dressing packet contains fish (anchovies) which is not declared on the product label.  The problem was discovered by the establishment during a routine quality assurance check of ingredient labels. The establishment then notified FSIS that the product may contain fish (anchovy), which is not declared on the label.

https://www.fsis.usda.gov/recalls-alerts/lpk1-recalls-ready-eat-chicken-caesar-wrap-products-due-misbranding-and-undeclared
LPK1 Recalls Ready-to-Eat Chicken Caesar Wrap Products Due to Misbranding and Undeclared Allergen

WASHINGTON, Feb. 23, 2025 – LPK1, a Renton, Wash. establishment, is recalling approximately 303 pounds of ready-to-eat chicken Caesar wrap products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product’s individually-wrapped Caesar dressing packet contains fish (anchovies), a known allergen, which is not declared on the product label.

NJ Firm Recalls Dark Chocolate Novelties Due to Undeclared Milk

Kayco, a Bayonne NJ company is recalling their Glicks Dark Chocolate Conettos because it may contain undeclared milk.  This recall was initiated after the company was notified by their Quality Control Department that a limited number of bags labeled as “Dark Chocolate Conettos” contained Milk Chocolate Conettos, which contains milk allergen that is not declared on the label.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kayco-issues-allergy-alert-undeclared-milk-limited-units-glicks-dark-chocolate-conettos
Kayco Issues an Allergy Alert on Undeclared Milk in Limited Units of Glicks Dark Chocolate Conettos
Summary
Company Announcement Date:  February 21, 2025
FDA Publish Date:  February 21, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk allergen
Company Name:  Kayco
Brand Name:  Glicks
Product Description:  Dark Chocolate Conettos

Frozen Supplemental Shakes Linked to Listeria Outbreak Impacting Long-Term Care Residents

The FDA and CDC are linking a multistate outbreak of Listeria monocytogenes infections  Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes.  This product, used a nutrient supplement, was used in long-term care facilities which would have high-risk consumers for Listeria.  Cases date back to 2018.  There have been 38 reported cases with 11 deaths.

"On November 25, 2024, FDA was notified about an outbreak of Listeria monocytogenes in the United States, with many ill people residing in long-term care facilities (LTCF) prior to illness onset. FDA’s traceback investigation identified that each of the LTCF who supplied invoice information for review from 2024 to present received a frozen supplemental shake of either Lyons ReadyCare or Sysco Imperial brand. As part of this investigation, FDA collected environmental samples and found the outbreak strain of Listeria."

"According to CDC, this outbreak includes cases dating back to 2018, with 20 cases across 2024 and 2025, and is currently ongoing. Epidemiologic evidence in previous investigations were unable to identify a source of the outbreak. As of February 21, 2025, a total of 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states. Of the 38 people for whom information is available, 37 people have been hospitalized. Eleven deaths have been reported. Of the 38 people for whom information is available, 34 (89%) reported living in long term care facilities or were hospitalized prior to becoming sick. Records reviewed from facilities indicated nutritional shakes were available to residents."

Lyons Magnus LLC (“Lyons Magnus”), Fresno CA, announced that it is voluntarily recalling 4 oz. Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes due to the potential for the products to be contaminated with Listeria monocytogenes. 

Case Counts
Total Illnesses: 38
Hospitalizations: 37
Deaths: 11
Last Specimen Collection Date: January 23, 2025
States with Cases: AL, CA, CO, CT, FL, IL, IN, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WA, and WV

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-frozen-supplemental-shakes-february-2025
Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes (February 2025)
Content current as of: 02/21/2025
Do not sell or serve Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes. FDA’s investigation is ongoing.

Importer Recalls Snack Products After Foreign Supplier Fails on Allergen Labeling

ZB Importing LLC. Cicero, IL, is voluntarily recalling certain lots of six varieties of Ulker Brand snack rolls, biscuits, and wafers due to undeclared wheat, egg and/or milk in the Ingredient List and/or Contains Statement on the product labels.  This mislabeling was discovered following receipt of a single consumer complaint involving an allergic reaction. The issue originated from a supplier who inadvertently failed to fully disclose all allergens while translating the ingredient list. [The company is] actively working with the supplier to implement stricter labeling controls, including an additional verification process for multilingual labels.

Ulker branded product is imported from Turkey.

The importer in this case, ZB Importing LLC., is responsible for assuring proper allergen labeling through their foreign supplier verification program (FSVP).   Allergens would have been identified on the hazard analysis for  product from that company, and the importer would need measures to ensure that proper allergen control was implemented, specifically in this case, label declaration of allergens.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/zb-importing-issue-voluntary-recall-and-allergy-alert-undeclared-egg-wheat-and-milk-certain-ulker
ZB Importing Issue Voluntary Recall and Allergy Alert on Undeclared Egg, Wheat and Milk in Certain Ulker Brand Products
Summary
Company Announcement Date:  February 18, 2025
FDA Publish Date:  February 20, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen (wheat, eggs, milk)
Company Name:  ZB Importing LLC
Brand Name:  Ulker
Product Description:  Snack rolls, biscuits, and wafers

Texas Firm Recalls Snack Mix For Missing Allergen Labeling

KEDAKE, INC. of Houston, TX is recalling it’s 2 lb packages of Las Ollas Botana Mix Snacks because they may contain undeclared Sesame, Soy, Wheat, Yellow No 5, Yellow No 6, and Red No 6.  Las Ollas Botana Mix Snacks 2 lb packages were distributed in Texas and reached consumers through both wholesale and retail stores.   The recall was initiated after the FDA discovered in a routine inspection that the product containing the Sesame, Soy, Wheat, Yellow No 5, Yellow No 6, and Red No 6 was distributed in packaging that did not reveal the presence of these ingredients and subsequent investigation indicated that the problem was caused by a production printing problem with the label.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kedake-inc-issues-allergy-alert-undeclared-sesame-soy-wheat-yellow-no-5-yellow-no-6-and-red-no-6
Kedake Inc. Issues Allergy Alert on Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6 in Botana Mix Snacks
Summary
Company Announcement Date:  February 20, 2025
FDA Publish Date:  February 20, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat, sesame, soy, yellow 5, yellow 6, red 6
Company Name:  Kedake Inc
Brand Name:  Las Ollas
Product Description:  Las Ollas Botana Mix Snacks and Delights 2 lb packages

PSU Food Safety News Blog Ranked in Top 10 Food Safety Blogs for 2025

 According to Feedspot, a global blog and podcast hosting site, Penn State Food Safety News is ranked as one of the top food safety blog sites in the world.  For 2025, Penn State Food Safety News is ranked #9, breaking into the top ten!

https://bloggers.feedspot.com/food_safety_blog/

Thanks to all of you who continue to support our effort in bringing you the important issues involving food safety!

Georgia Firm Recalls Snack Pack Product for Undeclared Allergens After Incorrect Back Label Applied

Naturipe Value Added Fresh LLC. of Alma, GA, is recalling its 2.1 oz./60 gram packages of "Berry Buddies, Berries & Pancakes" bento box snack packs because they contain wheat and EGGS that were not declared on the label.  The recall was initiated after it was discovered that the incorrect back label was placed on the back of the package. Because of this, the allergens of WHEAT and EGGS were not listed on the label. Subsequent investigation indicates the problem was caused by a production label changeover failure which has since been corrected.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/naturipe-value-added-fresh-llc-issues-allergy-alert-undeclared-wheat-eggs-berry-buddies-berries
Naturipe Value Added Fresh LLC Issues Allergy Alert On Undeclared Wheat & Eggs In "Berry Buddies, Berries & Pancakes” Lot # 1097901
Summary
Company Announcement Date:  February 18, 2025
FDA Publish Date:  February 19, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen (wheat, eggs)
Company Name:  Naturipe Value Added Fresh LLC
Brand Name:  Naturipe Snacks
Product Description:  Berry Buddies, Berries & Pancakes bento box snack packs

Milk Chocolate Covered Macadamias Recalled for Undeclared Almonds

Mauna Loa Macadamia Nut Company LLC of Kea’au, HI is voluntarily recalling one batch of its Mauna Loa Milk Chocolate Covered Macadamias snack (1oz) pouches, due to the presence of undeclared almonds which are an allergen.  The recall was initiated after Mauna Loa’s internal quality control process identified that the affected batch, manufactured by a third-party co-manufacturer, contained undeclared almonds. Immediate action was taken to contain the affected product, notify the third-party co-manufacturer, alert consumers and distributors, and report the issue to the FDA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mauna-loa-macadamia-nut-company-llc-issues-product-recall-undeclared-almonds-mauna-loa-milk
Mauna Loa Macadamia Nut Company, LLC Issues a Product Recall on Undeclared Almonds in Mauna Loa Milk Chocolate Covered Macadamias (1oz) Pouches
Summary
Company Announcement Date: February 15, 2025

FDA Publish  Date: February 15, 2025

Product Type: Food & Beverages

Reason for Announcement:  Undeclared almonds

Company Name: Mauna Loa Macadamia Nut Company, LLC

Brand Name: Mauna Loa

Product Description: Mauna Loa Milk Chocolate Covered Macadamias  

MN Bakery Recalls Mislabeled Muffins for Undeclared Walnuts

JE Bakery 2019, LLC, doing business as Broadway Bakery, Minneapolis MN is voluntarily recalling its Raisin Bran Muffin 6 count due to a labeling error. The affected product was mislabeled and instead contains Glorious Morning Muffins, which contains Walnuts, a known allergen not declared on the label.

Bamboo Shoots Recalled for Temperature Abuse, Botulism Potential?

AKT Trading Inc of Torrance, California is recalling 120 packages of Menma Ajitsuke Prepared Bamboo Shoot Product, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.  This issue was discovered on 1/14/2025 at the Tokyo Central Costa Mesa retail store where the product was found being sold under ambient (non-refrigerated) conditions. The missing "Keep Refrigerated" label likely contributed to this issue. The product was immediately removed from sale at this location. Consumers who have purchased the affected product with the specified expiration date are urged not to consume it. Consumers should discard the product or return it to the place of purchase for a full refund.

Technically, this vacuum packed product must have a secondary barrier (low Aw, low pH, etc) so that one would not need to rely on refrigeration because of issues where the product would be temperature abused. Otherwise, temperature control would be preventive control needed to be maintained throughout the supply chain, which is not likely for a retail product such as this.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akt-trading-inc-recalls-seasoned-bamboo-shoots-because-possible-health-risk
AKT Trading Inc. Recalls Seasoned Bamboo Shoots Because of Possible Health Risk
Summary
Company Announcement Date:  February 11, 2025
FDA Publish Date:  February 12, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness - Botulism
Company Name:  AKT Trading Inc.
Brand Name:  CHOSHIYA
Product Description:  Menma Ajitsuke Prepared Bamboo Shoot

Frozen Pasty Recalled for Undeclared Egg

The USDA-FSIS is issuing a public health alert for frozen, fully cooked ready-to-eat (RTE) meat and poultry pasties, produced by the Pasty Oven, Florence, WI, due to misbranding and an undeclared allergen. The products were produced using an egg wash, which contains egg, a known allergen, that is not declared on the product label.  FSIS discovered the problem during routine labeling review activities when it found that the egg ingredient was not listed on the final product label.



https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-frozen-ready-eat-meat-and-poultry-pasties-due
FSIS Issues Public Health Alert for Frozen Ready-To-Eat Meat and Poultry Pasties Due to Misbranding and Undeclared Allergen
The Pasty Oven, Inc.

FSIS Announcement

WASHINGTON, Feb. 12, 2025 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen, fully cooked ready-to-eat (RTE) meat and poultry pasties due to misbranding and an undeclared allergen. The products were produced using an egg wash, which contains egg, a known allergen, that is not declared on the product label. FSIS is issuing this public health alert to ensure that consumers with allergies to eggs are aware that this product should not be consumed. A recall was not requested because the affected products are no longer available for purchase.

FDA Begins Email Communications Listing Weekly Recap of Recalls

We just received an email from FDA titled Weekly Recap of Recalls...for each of the weeks of this year starting January 12 to 18, 2025.  Those of you who are receiving recall information from FDA already probably received the series of emails as well.  Good idea.

Recent Recall for Oysters Highlights Norovirus Risk

Over the past year, there have been 14 recalls for oysters after foodborne illness outbreaks, primarily due to norovirus infections.  Five of those outbreaks / recalls occurred over the past 4 months (below), with the last one due to oysters harvested in Louisiana.   

Raw oysters are a risk for viral and bacterial pathogens.  As filter feeds, they capture the contaminants in the water column and those contaminates are consumed when the oysters are eaten raw.  The government requires shellfish identification tags to be placed on the shellfish when harvested and these tags accompany the shellfish to the point of sale, at which point, they must be kept on file in the event of an outbreak.  This allows investigators to identify the site in which the oysters were harvested and then issue a source specific recall.

Louisiana Oysters - Norovirus - Feb 2025

The Louisiana Department of Health has issued a recall for certain oysters that were harvested from Louisiana due to an outbreak of norovirus illnesses. The oysters were harvested from Louisiana Area 3 from 1/10/2025 through 2/4/2025. The oysters were shipped to distributors and retailers in AL, FL, LA, MD, MS, NC, and TX and may have been distributed to other states as well. The FDA is advising restaurants and food retailers not to serve or sell and to dispose of, and consumers not to eat, these oysters following the instruction provided below because they may be contaminated with norovirus.

Seafood Processor Recalls Canned Tuna of Various Brands for Can Lid Failure, Botulism Concern

Tri-Union Seafoods has made the decision to voluntarily recall select lots of canned tuna products sold under the Genova®, Van Camp’s®, H-E-B and Trader Joe’s brand names. This voluntary recall is out of an abundance of caution following the notification from our supplier that the “easy open” pull tab can lid on limited products encountered a manufacturing defect that may compromise the integrity of the product seal (especially over time), causing it to leak, or worse, be contaminated with clostridium botulinum, a potentially fatal form of food poisoning.

While some news articles are stating this recall is botulism contamination, it is better stated as a can lid failure issue that could result in Clostridium botulinum contamination, and thus a risk for botulism.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tri-union-seafoods-issues-recall-select-genovar-van-campsr-h-e-b-and-trader-joesr-tuna-cans-due
Tri-Union Seafoods Issues Recall of Select Genova®, Van Camp’s®, H-E-B and Trader Joe’s® Tuna Cans Due to Clostridium Botulinum Risk
Summary
Company Announcement Date:  February 07, 2025
FDA Publish Date:  February 10, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness - Botulism
Company Name:  Tri-Union Seafoods
Brand Name:  Genova, Van Camp’s, H-E-B, Trader Joe’s
Product Description:  Canned tuna

Message Boards Are Not a Good Information Source for Recalls

There was evidently a rumor of an egg recall that circulated on web message boards over the past week.  Shows how many people buy into unverified news such as delivered through internet message boards.

Forbes
https://www.forbes.com/sites/stephaniegravalese/2025/02/06/egg-recall-rumors-are-spreading--heres-what-you-need-to-know/
Egg Recall Rumors Are Spreading—Here’s What You Need To Know
Stephanie Gravalese
Contributor

Was There a Recall on Eggland's Best Eggs? Here's What We Know

If you've seen posts claiming Eggland's Best eggs have been recalled, you're not alone. Over the past week, rumors have spread across social media, with people warning others to check their cartons, return eggs to stores, or avoid buying them altogether.

But is there actually an Eggland's Best eggs recall 2025? No.

TX Establishment Recalls Sausage Product After Complaint for Foreign Material - A Pen

 D.J.’s Boudain, LLC, a Beaumont, Texas, establishment, is recalling approximately 17,720 pounds of boudain sausage link products that may be contaminated with foreign materials, specifically pieces of a pen.  The problem was discovered after the establishment received a consumer complaint involving the discovery of a piece of a pen while eating the Original Boudain sausage links product.

There has been one reported oral injury associated with consumption of this product. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury should contact a healthcare provider.

One of our favorite examples for foreign material sources - employees with pens.  And this is what happens - employee drops the pen or places it in the wrong spot, falls into the product stream, gets blended or ground, ends up in finished product, and then injures a customer as they consume product with broken pen pieces.

So what does that lost pen cost?  In terms of production, over 8 tons of finished product.

A great example for sharing with employees.

https://www.fsis.usda.gov/recalls-alerts/djs-boudain-llc-recalls-sausage-link-products-due-possible-foreign-matter
DJ’s Boudain LLC Recalls Sausage Link Products Due to Possible Foreign Matter Contamination
FSIS Announcement

WASHINGTON, Jan. 31, 2025 – D.J.’s Boudain, LLC, a Beaumont, Texas, establishment, is recalling approximately 17,720 pounds of boudain sausage link products that may be contaminated with foreign materials, specifically pieces of a pen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Wisconsin Sprout Operation Recalls Sprouts After State Testing Finds Listeria

Jack and the Green Sprouts, Inc. of River Falls, WI is recalling 5oz packages of Alfalfa sprouts that expired on 1/29/25 because they have the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was noted after routine testing by the State of MN which revealed the presence of Listeria monocytogenes in expired 5oz package Alfalfa sprouts. Even though Jack and the Green Sprout’s tests from an independent lab had negative results confirmed on spent irrigation water & finished Product for the Alfalfa Lot #687 before release.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jack-and-green-sprouts-recalls-expired-alfalfa-sprouts-because-possible-health-risk
Jack and the Green Sprouts Recalls Expired Alfalfa Sprouts Because of Possible Health Risk
Summary
Company Announcement Date:  February 07, 2025
FDA Publish Date:  February 08, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Jack and the Green Sprouts, Inc.
Brand Name:  Jack & the Green Sprouts
Product Description:  Alfalfa Sprouts

NJ Firm Recalls Imported Tahini Paste After State Lab Detects Salmonella

Turkana Food Inc. Kenilworth, NJ is recalling 858 cases OF Aleppo Tahini Sesame Paste because it has the potential to be contaminated with Salmonella.  The recall was the result of a routine sampling performed by the Ohio Department of Agriculture which revealed that the finished products contained Salmonella. The company has ceased production and distribution of the products as FDA and the company continue their investigation to what caused the problem.  Product is imported from Turkey.
             
                                                
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/turkana-food-inc-recalls-aleppo-tahini-sesame-paste-1lb-16oz-because-possible-health-risk
Turkana Food Inc. Recalls Aleppo Tahini Sesame Paste 1lb (16oz) Because of Possible Health Risk
Summary
Company Announcement Date:  February 06, 2025
FDA Publish Date:  February 06, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness - Salmonella
Company Name:  Turkana Food Inc.
Brand Name:  Aleppo
Product Description:  Tahini Sesame Paste

Salmonella Outbreak Linked to Imported Mini Pastries

The FDA and CDC, in collaboration with state, local, and international partners, are investigating illnesses in a multistate outbreak of Salmonella Enteritidis infections linked to Sweet Cream-brand mini pastries manufactured in Italy and exported into the United States by Importations Piu Che Dolci Inc. of Quebec, Canada.  As of January 29, 2025, a total of 18 people infected with the outbreak strain of Salmonella have been reported from seven states. Of the 18 people for whom information is available, one person has been hospitalized

On January 21, 2025, FDA was notified about an outbreak of Salmonella in the United States, which is the same strain investigated in Canada. Canadian Food Inspection Agency (CFIA) informed FDA that their investigation linked their outbreak to Sweet Cream-brand mini pastries,

The recalled products were imported by two distributors in the U.S. who were contacted about the recall. One distributor had no product on hand, and the second distributor quarantined all product on hand and informed all of their downstream customers of the recall. As part of this investigation, FDA conducted traceback for one of the U.S. cases and identified that they were served recalled Sweet Cream-brand mini pastries at a restaurant prior to becoming sick. The restaurant received the pastries from one of the U.S. distributors.

The FSVP (Foreign Supplier Verification Program) was put in place to ensure that importer of this product can verify the foreign producer is meeting US standards including having a Food Safety Plan.  In this case, the FSVP importer would conduct a hazard analysis, determine significant hazards, and then put in verification procedures to ensure that supplier is controlling the significant hazards.  In a pastry product such as this, Salmonella would have been determined to be a significant hazard to be controlled through process control and then through sanitation control to prevent recontamination of the RTE pastry before packaging.

Case Counts
Total Illnesses: 18
Hospitalizations: 1
Deaths: 0
Last Illness Onset: December 6, 2024
States with Cases: CA, IL, MA, NC, NJ, NY, and PA
Product Distribution*: FL, NJ, NY, and PA

*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states



https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-mini-pastries-january-2025
Outbreak Investigation of Salmonella: Mini Pastries (January 2025)
Do not sell or serve recalled Sweet Cream-Brand Mini Pastries. FDA’s investigation is ongoing.

Rushing to Judgment on the FDA 483 Inspectional Observations of Onion Facility

It can be difficult in determining the exact cause of a foodborne illness outbreak, even for inspectors.  But it seems that it can be too easy to jump to conclusions, especially for the media, based upon pieces of information that become available.  A recent posting from Food Safety Strategy titled The Mischaracterization of a 483  provides a good analysis of the FDA's 483 report of Inspectional Observations and how they can be difficult to judge, especially for those who are not familiar with food observations.  While this analysis did not reference a specific 483 report, I immediately thought of the report of the facility that was responsible for the 2024 E. coli outbreak linked to sliced onions sold at McDonalds.

To read through this, one can easily say the inspector is leaning to environmental contamination issue due to lack of cleaning.  Certainly some of the media conveyed that thought.  However, while this facility had 'potential' issues based upon what he inspector observed, there is no hard evidence provided and plenty of questions that are not answered.

As pointed out in the article cited above, fresh operations are going to have pooling water.  It is a wet operation.  The 483 cites 'apparent biofilm',  but there was no analysis to determine if it was bacteriological in origin.  In fact, no environmental testing was mentioned in the report.   

The presence of Listeria and other pathogens in these types of facilities is going to happen.  There needs to be recognition of whether that contamination is endemic or transient.

It is important to recognize that this is a process with no lethality / kill step.  The biggest issue with contamination is just as much or more of a raw material issue than a facility issue.  And the 483 does not delve into this fact that contamination may likely have been on the product.  And there has been some research evidence for internalization of pathogenic organisms in produce including onions that are grown in soil.  

Not to argue with what the inspector observed, but one must be cautious about jumping to conclusions based upon these observations without additional information including field testing, product testing, etc.

https://www.koaa.com/news/covering-colorado/inspectors-find-dozens-of-violations-at-taylor-farms-in-colorado-springs
FDA 483 Inspectional Observations
Taylor Farms Colorado, Inc.

6th &  Kipling St. (P.O. Box 25087)

Denver, CO 80225-0087

(303)236-3000  Fax:(303)236-3100

OBSERVATION 1
You did not implement your sanitation preventive control, monitoring, corrective action and verification procedures.

NC Raw Pet Food Company Continues to Issue Recalls For Pathogens Found by State Testing

Blue Ridge Beef, of Statesville, NC is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a contamination of Salmonella. Lot # N25/12/31 (Lot numbers are stamped in the clips on the end of the chubs/bags) UPC# 854298001054.  Samples of the product was collected on 01/08/25 by the North Carolina Department of Agriculture and tested by the North Carolina Department of Agriculture Food and Drug Protection Laboratory. The product tested positive for Salmonella.  On 01/27/2025 the firm was notified by the FDA that the product tested positive for Salmonella.

This company has a significant history of recalling product due to the presence of pathogens.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-ridge-beef-issues-recall-blue-ridge-beef-natural-mix-due-salmonella-contamination
Blue Ridge Beef Issues a Recall of Blue Ridge Beef Natural Mix Due to Salmonella Contamination
Summary
Company Announcement Date:  January 31, 2025
FDA Publish Date:  January 31, 2025
Product Type:  Animal & Veterinary  Food & Beverages   Pet Food
Reason for Announcement: Salmonella contamination
Company Name:  Blue Ridge Beef
Brand Name:  Blue Ridge Beef
Product Description:  Natural Mix

Baby Teething Chew Stick Recalled and Discontinued After Choking Incidents

Gerber Products Company is initiating a recall and discontinuation of all batches of GERBER® SOOTHE N CHEW® TEETHING STICKS due to a potential choking hazard for babies and young children.  The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm.

Consumers who may have purchased GERBER® SOOTHE N CHEW® TEETHING STICKS should not feed this product to their child and can return the product to the retailer where it was purchased for a refund. Anyone concerned about an injury or illness should contact a health care provider.

According to the Gerber website, This voluntary recall and discontinuation is isolated to GERBER® SOOTHE N CHEW® TEETHING STICKS – STRAWBERRY APPLE and GERBER® SOOTHE N CHEW® TEETHING STICKS – BANANA. It does not impact any other Gerber products such as Gerber® Teethers Gentle teething wafers and Gerber® TEETHER WHEELS.

It seems to me that this product design would be a bad idea.  Anyone with a dog knows that chew sticks can be an issue with choking for some dogs, so the same issue would apply to this.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gerber-products-company-announces-recall-and-discontinuation-all-batches-gerberr-soothe-n-chewr
Gerber Products Company Announces Recall and Discontinuation of All Batches of Gerber® Soothe N Chew® Teething Sticks Due To Choking Hazard
Summary
Company Announcement Date:  January 31, 2025
FDA Publish Date:  January 31, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential choking hazard for babies and young children
Company Name:  Gerber Products Company
Brand Name:  Gerber
Product Description:  Gerber® Soothe N Chew® Teething Sticks