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Brashears is back at the USDA's top food safety post

Food Safety News - December 18, 2025 - 12:06am

Mindy Brashears from Texas Tech University was near confirmation on Dec. 17 by the U.S. Senate for an unprecedented second term as Under Secretary of the USDA for food safety. President Trump nominated her on June 2 to the same position she held during his first term in the White House.

Her confirmation comes as part of a group of 97 Trump executive and judicial nominees readied for approval by a single Senate vote. Majority Leader John Thune, R-SD, amended Senate rules to get more Trump appointments confirmed after Senate Democrats ceased moving the nominees at historic speeds. 

Thune calls the group confirmation, which passed on a 53-47 procedural vote, a “tactical nuclear” response to the slowdown. The final vote should come today.

The Senate Committee on Agriculture, Nutrition, and Forestry managed Brashear’s nomination. It held a confirmation hearing on Oct. 29 and reported her appointment favorably to the full Senate on Nov. 3.

Brashears fills a 333-day vacancy in the nation’s top food safety position that has been open since Dr. Jose Emilio Esteban left the job at the end of the Biden administration.  

The last time Brashears was confirmed by the Senate as Under Secretary for Food Safety at USDA in 2020, the position had been vacant for more than six years. This was due to a combination of events — President Obama opted not to name a successor to Dr. Elizabeth Hagen when she left government, and it took President Trump more than a year to nominate Brashears during his first term.

Brashears again leaves Texas Tech University as a professor of food safety and public health and as director of the TTU International Center for Food Industry Excellence. Brashears was an expert witness in the June 2017 trial of BPI v. ABC News. 

As one of the nation’s top beef experts, Brashears told the Elk Point, SD, jury that BPI’s product was “definitely a meat and definitely beef” and not “pink slime” as repeatedly depicted by ABC News. Shortly after her testimony, the Disney-owned ABC News agreed to settle with the Dakota Dunes-based BPI. Financial experts who follow Disney said it paid at least $177 million to resolve the product-defamation lawsuit.

A past-chair of the National Alliance for Food Safety and Security, Brashears will again chair the U.S. Codex Steering Committee, which organizes the U.S. delegation to the Codex Alimentarius Commission. The Codex Alimentarius, or "Food Code" is a collection of international standards, guidelines and codes of practice adopted by the Codex Alimentarius Commission. The Commission, also known as CAC, was established to protect consumer health and promote fair practices in food trade. It held its first meeting in 1963.

Her responsibilities also include oversight of the USDA's Food Safety and Inspection Service, including policies and programs.  FSIS regulates the nation’s meat, poultry, certain egg products, and catfish.

The Undersecretary for Food Safety was created by the Department of Agriculture Reorganization Act of 1994, which was signed into law in October 1994.   

In addition to Brashears, Esteban and Hagen, the others who have held food safety posts are: Dr. Richard A. Raymond (July 2005 to January 2009); Elsa A. Murano (October 2001 to December 2004); and Catherine Woteki (July 1997 to January 2001).

The act requires that the president name an Under Secretary for Food Safety who must be selected from among individuals with specialized training or significant experience in food safety or public health programs.

FDA releases additional details of outbreak investigations

Food Safety News - December 18, 2025 - 12:05am

The Food and Drug Administration has released additional information on several foodborne illness outbreaks in Executive Incident Summary Abstracts. Portions of the reports were redacted.

For an outbreak of Salmonella Oranienburg infections traced to alphafa sprouts reported in August this year, the FDA is now reporting that illnesses with the same genetic fingerprint were reported in 2009. 

The outbreak illnesses were linked to sprouts from a hydroponic farming business in Arizona, but the FDA did not report the name of the business in its executive summary. Similarly, the FDA has not reported where outbreak patients said they bought the sprouts.

Both the FDA and the Centers for Disease Control and Prevention identified sprouts as the leading item of interest based on the genetic link and patient interviews.

On Aug. 29 the FDA conducted an onsite inspection of the implicated farm and collected product samples and samples from the production area. The FDA issued a form A483 report indicating violations of federal law related to sanitation and building problems.

For an outbreak of Salmonella Anatum infections traced to Deep brand frozen moth and mung bean sprouts, the outbreak strain was found in product samples. The sprouts were recalled.

There were 12 confirmed patients in 11 states. Illness onset dates ranged from Oct. 22, 2024, to Aug. 5, 2025.

The FDA conducted inspections at Chetak Chicago LLC as well as a for-cause inspection of the company’s Foreign Supplier Verification Program (FSVP) at its San Francisco location. The San Francisco inspection closed with the FDA issuing a form 483 report informing the company that its operation was in violation of federal law.

The FDA issued an Import Alert for the enhanced screening of products from an unnamed foreign company.

For an outbreak of Salmonella Enteritidis that ran from April through August this year, the FDA’s executive summary confirmed that eggs from Country Eggs LLC in California were the source of the infections. There were 105 confirmed patients from 14 states from coast to coast. Ninety percent of the patients reported eating eggs before becoming ill.

Some of the patients reported eating eggs at restaurants. Restaurant locations reported using brown eggs branded as Jidori, Mizuho, or eggs with a product description including Golden Yolks or Sunshine Yolks that were supplied by Country Eggs LLC. In August, he company initiated a recall of all eggs with sell-by dates between July 1 through Sept. 16.

A comprehensive Egg Rule Inspection of Country Eggs LLC was conducted on August. 26. The FDA issued a form 483 inspection report noting gaps in the company’s Salmonella Enteritidis prevention plan and required records that constitute violations of federal law.

Egg samples collected at the company’s production facility were positive for the outbreak strain.  

 

ByHeart infant botulism cases level off

Food Safety News - December 18, 2025 - 12:04am

Federal authorities are reducing the frequency of reports on the infant botulism outbreak traced to ByHeart powdered infant formula.

So far the outbreak has sickened 51 babies across 19 states. All of the babies have required hospitalization but none have died. The Centers for Disease Control and Prevention has determined that some of the illnesses date back to December 2023. It was originally thought that the outbreak began in August this year.

According to the Food and Drug Administration reports of illnesses in the outbreak have slowed since the most recent update on Dec. 10. Therefore, the CDC will no longer be releasing weekly updates. Rather, the agency will only update the public “when new information becomes available.”

As of Nov. 11, all ByHeart products have been recalled. On Dec. 12 the FDA sent letters to officials at Albertsons, Kroger, Target and Walmart warning them because they had not promptly removed the recalled products from their store shelves and that such inaction was a violation of federal law.

The recalled ByHeart formula was available at other retailers and via online sales.

Testing by the California Department of Public Health, as well as ByHeart, found botulism in the company’s infant formula.

Sample Collected/Analyzed by

Product

Test Result

Toxin Type

CDPH

Opened container of ByHeart Infant Formula (Batch No. 251131P2)

Positive

Type A

ByHeart

ByHeart Infant Formula (Unreported batches)

Positive

Type A

ByHeart

ByHeart Infant Formula (Unreported batches)

Positive

Type A

ByHeart

ByHeart Infant Formula (Unreported batches)

Positive

Type A

ByHeart

ByHeart Infant Formula (Unreported batches)

Positive

Type A

ByHeart

ByHeart Infant Formula (Unreported batches)

Positive

Type A

Symptoms of Infant botulism  

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.

Any infants with signs of botulism should be immediately taken to a doctor or emergency room.

Recommendations

  • Parents and caregivers should stop using any ByHeart infant formula products immediately.
    • If your child consumed ByHeart formula and is experiencing symptoms seek immediate medical attention.
    • If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.
    • If you still have the formula in your home, you should:
      • Take a photo or record the information on the bottom of the package.
      • Keep the container in a safe spot and be sure to label that product as DO NOT USE.
      • If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out. 
    • Parents and caregivers from any state who have concerns about this outbreak and infant botulism can also contact the California Department of Public Health (CDPH) hotline at 833-398-2022 The hotline is available Monday to Friday from 7 a.m. to 7 p.m. PST.
    • Wash items and surfaces, containers and utensils that may have touched the formula using hot soapy water or a dishwasher.

Researchers highlight foodborne risks at events

Food Safety News - December 18, 2025 - 12:01am

A review led by health experts has revealed that foodborne illnesses are among the most common public health threats at youth-focused mass gatherings.

The analysis was done to identify and understand the risks at multi-day events. It included 23 records, published between 1993 and 2022, that covered 19 events in various countries. Findings were published in the journal Public Health.

Scientists from Flinders University in Australia said youth-specific vulnerabilities – such as risk-taking behaviors and limited compliance with hygiene protocols – reinforce the need for tailored public health strategies. 

Foodborne infection danger
The main issue was infectious disease outbreaks, but foodborne outbreaks were also reported at four events, three linked to bacteria and one to a viral agent.

These events had a mean duration of four days with a mean of 6,980 attendees and a range of 350 to 20,000 people. They occurred in Australia, Greece, Japan, and the UK. Two were sporting events, one was a music festival, and the other was a youth camp.

Outbreaks were caused by Campylobacter jejuni, Clostridium perfringens, Hepatitis A, and Staphylococcus aureus enterotoxins A and C.

They were found following surveillance reports to the local public health authority. Case control investigations identified implicated foods as contaminated coleslaw, ground (minced) beef, crepes, and unpasteurized milk.

The outbreak of Hepatitis A was because of an infected food handler not taking proper precautions while preparing coleslaw, while the other outbreaks were from contaminated foods that were not appropriately cooked or handled prior to consumption by attendees.

How to minimize risk
Three of the four public health authorities reportedly developed food handling policies for future events.

Safety protocols were identified as important for preventing foodborne outbreaks, with recommendations including that public health authorities ensure the development and enforcement of food and water safety protocols, and that event organizers make sure all food handlers have compliant training in hygienic food preparation.

Jacqueline Stephens, Flinders University epidemiologist and lead author on the study, said findings highlight the importance of proactive planning and collaboration between event organizers and health authorities.

“Close social interactions, shared accommodation, and sometimes risky behaviors create the perfect storm for disease transmission. Simple measures like vaccination, good hygiene, and safe food practices can make a huge difference in safeguarding against the risks,” she said.

“Foodborne illness can ruin a festival experience and, in some cases, lead to serious health consequences. Organizers need to make sure vendors follow strict hygiene protocols.”

Co-author Dr. Josh Trigg said attendees play a vital role in staying safe.

“If you’re heading to a multi-day event, check your vaccinations, wash your hands regularly, and be mindful about what you eat and drink. Public health isn’t just about big systems – it’s about individual choices that protect you and the people around you.”

New Zealand looks to strengthen import rules

Food Safety News - December 18, 2025 - 12:01am

New Zealand is planning to change the import requirements for several products, including stricter measures on tahini and sesame paste.

A comment period covers dried spices (chili, pepper, and paprika); milk and dairy products; bivalve molluscan shellfish (BMS) and BMS products, and tahini and sesame paste products.

Coffee cake recalled because of undeclared allergen

Food Safety News - December 17, 2025 - 6:40pm

James Skinner LLC is recalling of a lot of Publix Maple Walnut Coffee Cake because the wrong ingredient label was applied to the packaging on certain units.

The product may represent a serious or life-threatening health risk to people with a walnut allergy if they consume the impacted product. 

The recalled product was packaged in cases with Maple Walnut Coffee Cake labels but then inadvertently individually labeled as Publix Raspberry Coffee Cake. The Raspberry Coffee Cake label declares “processed on equipment that also processes almonds, pecans and walnuts” but does not include walnuts in the ingredient list.

Observable through the clear lid, the product has visible walnuts on top of the cake and brown maple topping, whereas Raspberry Coffee Cake has no walnuts on top and red topping. The issue was discovered by a retail store employee who observed the visible walnuts on top of the product and noticed that the product had a Raspberry Coffee Cake label instead of a Maple Walnut Coffee Cake label.

The recalled product was shipped to Sourcing & Distribution Specialists, Winter Haven, FL, who then further distributed the product to Publix retail stores throughout 8 states including Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee and Virginia.

The recalled coffee cake can be identified by the following label information: Publix Raspberry Coffee Cake; 14-ounce; Lot code 5309; SKU 54591; date of manufacture 11/5/25.

No reports of injury or illness have been reported to date.

Company recalls frozen tamales because of Listeria risk

Food Safety News - December 17, 2025 - 6:28pm

Primavera Nueva Inc. is voluntarily recalling certain lots of its 4-count tamales because the products have the potential to be contaminated with Listeria monocytogenes.

Product was distributed by Primavera Nueva Inc. in California and Nevada to retail stores.

The following 4-count tamales, produced between Oct. 10, 2024 and Oct. 10, 2025 are included in the recall:

  • Roasted Green Chile & Jack Cheese
  • Black Bean Bonanza & Jack Cheese
  • Butternut Squash w/ Roasted Green Chiles & Cheese
  • BBQ Chipotle Bean & White Cheddar
  • Mushroom Spinach & Salsa with Two Cheeses
  • Roasted Green Chile
  • Black Bean Bonanza
  • Butternut Squash w/ Roasted Green Chiles
  • Mushroom Spinach & Salsa

The company did not include any other identifying information in its recall notice.

No illnesses have been reported to date.

The products were made with a frozen ingredient labeled “Not Ready to Eat. Must Be Thoroughly Cooked Before Eating.” During an FDA inspection on Oct. 10, 2025, the agency determined that earlier production records did not consistently verify internal cooking temperatures needed to control potential biological hazards, including Listeria monocytogenes.

According to its recall notice, Primavera Nueva has corrected the issue — enhanced cooking-temperature monitoring and verification have been in place since Oct. 11, 2025.

About Listeria infections
Food contaminated with Listeria monocytogenes may not look, smell or taste spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the recalled tamales and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, other complications and death. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

Non-profit group reveals severity of ongoing Salmonella contamination in poultry

Food Safety News - December 17, 2025 - 12:05am

The country’s largest poultry producers had 100 percent of their plants receive the worst USDA ratings for Salmonella contamination in 2023 and 2024, but the federal agency does not have a mechanism to close or discipline those plants.

The stunning statistics are included in a new report from Farm Forward, a non-profit group that supports interdisciplinary research and undergraduate teaching about the cultural significance of animals and animal agriculture.

Restaurant fined after Salmonella outbreak

Food Safety News - December 17, 2025 - 12:04am

A food business in England has been fined for causing a Salmonella outbreak in 2024.

Palm by H2O Limited in Coventry and company official Mohammed Naveed pleaded guilty at Coventry Magistrates Court in September and appeared before Birmingham Magistrates Court in December for sentencing.

FSA raises concerns about safety of Dubai chocolate

Food Safety News - December 17, 2025 - 12:02am

The Food Standards Agency (FSA) has advised people with allergies to avoid Dubai-style chocolate.

Some of these products may contain allergens such as peanuts and sesame that are not declared on the label.

As part of surveillance work, 50 samples were tested in the UK for undeclared peanuts, sesame, mycotoxins, and colors. Full results are not known but the analysis raised several issues of concern.

Bengal King Jhal Chanachur treats recalled because of undeclared peanuts

Food Safety News - December 16, 2025 - 8:57pm

South Asian Food Inc. of Maspeth, Queens, NY, is recalling Bengal King Jhal Chanachur food treats because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reactions if they consume these products.

The recalled Bengal King Jhal Chanachur were distributed nationwide in retail stores and through mail orders. The product comes in a 12.34-ounce (350gm), clear plastic jars marked with lot B No.HCNCU1205/24 on the top and with an expiration date of June-2026 stamped on the side. The product UPC code is 8941153046243.

No illnesses or allergic reactions involving this product have been reported to date.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed that the peanut-containing product was distributed in packages that did not reveal the presence of peanuts.

Pound cakes recalled because of undeclared soy

Food Safety News - December 16, 2025 - 4:40pm

Ukrop’s Homestyle Foods LLC of Richmond, VA, announced today that it is recalling four varieties of its decorated pound cakes because of an undeclared soy allergen.

A cake releasing agent containing soy was used to prevent sticking for the cakes listed below only. These products may contain soy, a known allergen, which is not declared on the product label.

Soy allergies can cause mild symptoms such as hives and itching to severe and life-threatening anaphylaxis.

All of the implicated products have a best-by date of Dec. 15. The recalled products and identifying label information are as follows:

  • 8-inch pound cake with buttercream icing/pink roses with a net weight of 44 ounces and a UPC number of 72252591452;
  • 8-inch pound cake with buttercream icing/red roses with a net weight of 44 ounces and a UPC number of 72252591456;
  • 6-inch pound cake with buttercream icing/red roses with a net weight of 33 ounces and a UPC number of 72252591820; and 
  • 6-inch pound cake with buttercream icing/confetti with a net weight of 30 ounces and a UPC number of 72252591849.

The recalled pound cakes are available from the following retailers:

  • Kroger Mid-Atlantic in Virginia and West Virginia
  • Ukrop's Market Hall in Richmond, VA

Outbreaks rise past 6,550 in Europe

Food Safety News - December 16, 2025 - 12:03am

France reported the most outbreaks in Europe with more than 2,000 in 2024 while the Netherlands also had more than 1,000 outbreaks, according to recently released statistics.

There were more foodborne outbreaks, patients, and hospitalizations across the EU than in 2023, although the number of deaths decreased. Overall, 6,558 outbreaks, 62,481 patients, 3,336 hospitalizations and 53 deaths were recorded for 2024 compared to 5,728 outbreaks, 52,215 cases, 2,896 hospitalizations and 65 deaths in 2023.

A total of 102 foodborne outbreaks, 1,583 illnesses, 185 hospitalizations and two deaths occurred in eight non-EU member states in 2024.

A report published by the European Food Safety Authority (EFSA) and European Centre for Disease Prevention and Control (ECDC) showed an increase in outbreaks for 18 member states, while there was a decrease in seven nations. The biggest waterborne event had 851 cases and was a norovirus outbreak in Spain.

Salmonella dominates outbreaks
France had more than 2,060 outbreaks, Netherlands reported 1,178, Spain had 805, and Belgium had 776. A total of 65 very large outbreaks with more than 100 patients each were reported.

Salmonella was identified in 1,238 outbreaks and was associated with the highest number of hospitalizations. Poland reported 283 outbreaks, France had 266, Spain had 240, and Slovakia had 132. Salmonella in egg products was the top pathogen/food vehicle followed by Salmonella in mixed food.

A total of 32 serovars were reported in outbreaks. Salmonella Enteritidis was the main one, followed by Typhimurium and monophasic Salmonella Typhimurium.

Norovirus and other caliciviruses were responsible for 631 outbreaks and the most patients while Listeria monocytogenes caused 17 deaths in 38 outbreaks.

Ten countries reported 22 outbreaks as part of multi-country events in 2024. Twenty were caused by Salmonella while Hepatitis A and Yersinia were behind one each.

Outbreak location and contributing factors
The agent was unknown in more than 40 percent of outbreaks with the Netherlands and Belgium the main reporters. Campylobacter was responsible for 314 outbreaks, Yersinia for 32, Shiga toxin-producing E. coli (STEC) for 31, Shigella for 30, and E. coli other than STEC for 26.

For bacterial toxin outbreaks, Staphylococcus aureus was linked to 148 incidents, Bacillus cereus to 127, Clostridium perfringens to 65, and Clostridium botulinum to 10.

Cryptosporidium was the top parasite behind outbreaks with 22. Histamine and scombrotoxin caused 56 outbreaks, while marine biotoxins caused 29 and mushrooms caused 26. Eight incidents were because of atropine and two were traced to lectins.

Cross-contamination and unprocessed contaminated ingredients were the most commonly reported contributory factors in strong-evidence outbreaks. This was followed by inadequate heat treatment and an infected food handler.

Restaurants or cafes or pubs or bars or hotels or catering services, multiple places of exposure in one country, school or kindergarten and canteen or workplace catering were the sites associated with the most cases.

Tyson makes a threat about the settlement with Oklahoma

Food Safety News - December 16, 2025 - 12:00am
It became known as the “Busload of Lawyers” case because of the number of attorneys required to represent all the parties.

Danone recalls frozen dessert because of stones

Food Safety News - December 15, 2025 - 10:47pm

Danone U.S. is voluntarily recalling its So Delicious Dairy Free Salted Caramel Cluster Non-Dairy Frozen Dessert pints because of the potential presence of foreign materials, such as small stones and other hard objects, within the cashew clusters.

The affected product was shipped to retailers nationwide.

Consumers can identify the recalled frozen product by looking for the following label information: SKU 136603, UPC 744473476138, and best-by date up to and including Aug. 8, 2027. The dates are printed on the bottom of the containers.

Consumers who have purchased the affected product should not consume it.

The company has already identified and corrected this issue, according to its recall notice.

Publisher's Platform: Botulism on the Shelf - Retailers - greedy or stupid?

Food Safety News - December 15, 2025 - 10:19pm

Seriously, babies getting botulism and you cannot seem to get the poison off your shelves? If any of you sold this product AFTER the recall date, and a kid became ill, you are subject to punitive damages.

Here are some excerpts from FDA Warning Letters of a few days ago. Links below are the full letters.

Target

On November 19, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Target stores. During this discussion, FDA requested information regarding actions you were prepared to implement to ensure recalled product was no longer available for purchase at Target stores nationwide. Despite follow-up emails from the FDA on November 20, 21, 24, and 26, 2025 and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale.

The inadequacy of Target’s recall response was further demonstrated on November 20, 2025, when Arkansas state partners observed ByHeart Whole Nutrition Infant Formula single-serve “anywhere pack” sticks on a Target store shelf with promotional “Sale!” signage offering a $2.00 discount on the recalled formula from November 16 to November 22, 2025. This observation indicates not only Target’s failure to remove recalled infant formula from the store shelves, but the active promotion and discounted sale of recalled infant formula product implicated in an infant botulism outbreak, more than a (b)(4) after Target was first made aware of ByHeart’s expanded recall.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/target-corporation-720399-12122025

Walmart

However, based on FDA’s review of information from state and local partners, the Agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (b)(4) Walmart store locations across 21 states from November 12 to November 26, 2025. This represents a period of (b)(4) days after Walmart was notified of the recall expansion. State and local partners reported several explanations offered by Walmart store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.

On November 18, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Walmart stores. During this discussion, FDA requested information regarding actions you were prepared to implement to ensure recalled product was no longer available for purchase at Walmart stores nationwide. Despite follow-up emails from the FDA on November 20, 21, and 24, 2025, and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-720400-12122025

Kroger

However, based on FDA’s review of information from state and local partners, the Agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (b)(4) Kroger store locations across 10 states from November 12, 2025, to November 19, 2025. This represents a period of (b)(4) days after Kroger was first notified of the initial recall and (b)(4) days after Kroger was notified of the recall expansion. State and local partners reported several explanations offered by Kroger store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.

On November 19, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Kroger stores. During this discussion, FDA requested information regarding actions you were prepared to implement to ensure recalled product was no longer available for purchase at Kroger stores nationwide. Despite follow-up emails from the FDA on November 20, 21, 24, and 25, 2025 and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kroger-company-720464-12122025

Albertsons

However, based on FDA’s review of information from state and local partners, the Agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (b)(4) Albertsons store locations across 11 states from November 12 to November 19, 2025. This represents a period of (b)(4) days after Albertsons was first notified of the initial recall and (b)(4) days after Albertsons was notified of the recall expansion. State and local partners reported several explanations offered by Albertsons store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.

On November 20, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Albertsons stores. During this discussion, FDA requested information regarding actions you were prepared to implement to ensure recalled product was no longer available for purchase at Albertsons stores nationwide. Despite follow-up emails from the FDA on November 20 and 24, 2025, and December 1 and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/albertsons-companies-incorporated-720465-12122025

More than 63 tons of pork sandwiches recalled because of plastic pieces

Food Safety News - December 15, 2025 - 10:00pm

E.A. Sween Company of Eden Prairie, MN, is recalling 127,887 pounds of pulled pork sandwiches that may be contaminated with pieces of plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The problem was discovered after the company received multiple complaints from consumers finding pieces of plastic in the barbecue pulled pork sandwich product. E.A. Sween Company determined that the plastic originated from the gallon plastic barbecue bottles used in production.

The barbecue pulled pork sandwich items were produced on various dates between Jan. 13 and Oct. 15. 

The FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them.

The sandwiches were shipped to retail locations nationwide and the Department of Defense.

The following product is subject to recall:

  • 5.5-oz. paper wrapped “Deli EXPRESS BBQ PULLED PORK on a sesame bun” sandwiches.   

The products subject to recall have the establishment number “EST. 2451” printed inside the USDA mark of inspection.               

There have been no confirmed reports of injury due to consumption of this product.

FDA warns retailers who failed to pull recalled ByHeart formula

Food Safety News - December 15, 2025 - 9:43pm

The Food and Drug Administration has warned four major retailers that they failed to meet statutory requirements to make sure their stores removed ByHeart infant formula after it was recalled.

The formula has been found to be the source of an outbreak of infant botulism that has sickened 51 babies across 19 states, with some of the illnesses dating back as far as December 2023.

The outbreak strain of botulism making babies sick has been found in unopened containers of ByHeart’s powdered infant formula. ByHeart initiated a recall of some of its product on Nov. 8 and expanded the recall on Nov. 11 to include all of its product.

Following the launch of the recall, the FDA began receiving notification from state and local health departments that some retailers had not removed the implicated products from their store shelves. As of Dec. 15, state local and federal inspectors had conducted more then 4,000 checks to make sure the recalled formula had been removed from store shelves. The vast number of those checks, more than 3,500 of them, were conducted by local and state authorities.

“Through this effort, we found that recalled infant formula continued to be found on store shelves — for over three weeks in one case, in over 175 locations across 36 states,” the FDA reported.

The four retailers that received individual warning letters because of the failures were Albertsons, Kroger, Target and Walmart. In all of the warning letters the FDA reminded the retailers that “the receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof for pay or otherwise, is a violation” of federal law.

The companies have 15 days to respond to the Dec. 15 warning letters with details about how they will correct their recall procedures or why they should not have to.

In an industry-wide letter the FDA described failures of retailers to properly recall the ByHeart formula.

“In one case, recalled product remained available for sale over three weeks after the recall was initiated, and in another case, the recalled product was offered at a discounted price, with the promotional period beginning five days after the recall had been expanded to include all infant formula products from the manufacturer in question. In several cases, recalled product returned by consumers was placed back on shelves,” according to the FDA letter.

Some of the deficiencies FDA and state and local health departments observed during recall checks at the retail level included:

  • Lack of awareness of recalls: some retailers were not aware that a recall had been issued for products in their inventory.
  • Lack of information to accurately identify all affected products: some retailers were uncertain about which lot numbers or product codes were subject to the recall, even though ByHeart recalled all of its product.
  • Incomplete removal of recalled items: even when aware of the recall, some retailers did not remove all affected products from shelves and storage areas.
  • Continued product distribution after recall notification: some retailers continued to receive and stock recalled products after being notified of the recall, and some accepted customer returns of recalled products and returned them to inventory for resale.

“While these failures to effectuate recalls mostly occurred at the retail level, they nonetheless signal systemic challenges that may exist across the industry,” the FDA said.

In the industry-wide letter, the FDA reminded businesses that they must have written recall plans. By law, the plans must include procedures that describe the steps to be taken, and assign responsibility for taking those steps. This includes:

  • Direct consignee notification:  Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food.
  • Public notification: Notify the public about any hazard presented by the food when appropriate to protect public health.
  • Effectiveness verification: Conduct effectiveness checks to verify that the recall is carried out.
  • Product disposition: Appropriately dispose of recalled food, through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

Warning letters sent to four major retailers
The publicly released warning letters sent to Albertsons, Kroger, Target and Walmart are partly redacted. Following are some details from the letters.

Target
Despite recall notifications, visits by regulators confirmed that recalled ByHeart Whole Nutrition Infant Formula remained available for purchase on shelves in at least (redacted) Target stores across 20 states well after the recall was initiated and subsequently expanded.

On Nov. 19, 2025, FDA held a call with Target officials to discuss the ineffectiveness of the recall. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Target stores nationwide. 

Despite follow-up emails from the FDA on Nov. 20, 21, 24, and 26 and Dec. 1, 3, and 8, Target has not provided the agency with any information demonstrating that corrective actions to implement the recall have been put into place.

“The inadequacy of Target’s recall response was further demonstrated on Nov. 20, 2025, when Arkansas state partners observed ByHeart Whole Nutrition Infant Formula single-serve ‘anywhere pack’ sticks on a Target store shelf with promotional ‘Sale!’ signage offering a $2.00 discount on the recalled formula from Nov. 16 to Nov. 22, 2025. This observation indicates not only Target’s failure to remove recalled infant formula from the store shelves, but the active promotion and discounted sale of recalled infant formula product implicated in an infant botulism outbreak, more than a (redacted) after Target was first made aware of ByHeart’s expanded recall,” according to the warning letter.

The full warning letter to Target can be found here.

Walmart
Based on FDA’s review of information from state and local partners, the agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (redacted) Walmart store locations across 21 states from Nov. 12 to Nov. 26. 

“State and local partners reported several explanations offered by Walmart store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification,” according to the warning letter.

On Nov. 18, FDA held a call with Walmart officials to discuss the ineffectiveness of its recall. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Walmart stores nationwide. Despite follow-up emails from the FDA on Nov. 20, 21, and 24 and Dec. 1, 3, and 8, Walmart has not provided FDA with any information demonstrating that corrective actions to implement the recall have been put in place.

The full warning letter to Walmart can be found here.

Kroger
Based on FDA’s review of information from state and local partners, the agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (redacted) Kroger store locations across 10 states from Nov. 12, 2025, to Nov. 19, 2025. 

State and local partners reported several explanations offered by Kroger store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.

On Nov. 19, the FDA held a call with Kroger officials to discuss the ineffectiveness of the recall within their stores. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Kroger stores nationwide. 

Despite follow-up emails from the FDA on Nov. 20, 21, 24, and 25 and Dec. 1, 3, and 8, Kroger officials have not provided FDA with any information demonstrating that corrective actions to implement the recall have been put in place.

The full warning letter to Kroger can be found here.

Albertsons
Based on FDA’s review of information from state and local partners, the agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (redacted) Albertsons store locations across 11 states from Nov. 12 to 19. 

State and local partners reported several explanations offered by Albertsons store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.

On Nov.20, 2025, FDA held a call with Albertsons officials to discuss the ineffectiveness of the recall within their stores. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Albertsons stores nationwide. 

Despite follow-up emails from the FDA on Nov. 20 and 24, and Dec. 1 and 8, the chain officials have not provided FDA with any information demonstrating that corrective actions to implement this recall have been put in place.

The full warning letter to Albertsons can be found here.

Food Safety News becomes nonprofit; launches reader-supported membership

Food Safety News - December 15, 2025 - 12:05am

Seattle, WA - Food Safety News announced today its transition to 501(c)(3) nonprofit status and the launch of FSN+, a reader-supported membership program, marking a significant milestone in the organization's commitment to independent food safety journalism. The transition addresses the evolving challenges facing independent media while ensuring the 16-year-old publication can continue delivering critical coverage without dependence on advertising revenue or personal funding.

The move ensures Food Safety News can maintain its independent investigative coverage of foodborne illness outbreaks, food recalls, regulatory developments, and emerging pathogens – work that serves food safety professionals, industry leaders, and conscious consumers worldwide. This transition comes at a critical time when independent food safety reporting is increasingly essential to public health awareness and industry accountability.

The FSN+ Membership Program
Food Safety News is introducing FSN+ membership to build a sustainable funding model centered on reader support. The membership structure includes:

Membership Benefits:

  • Members-only Sunday edition
  • Members-only FSN Daily newsletter (Monday - Friday)
  • Full access to all website articles
  • Ad-free website reading experience
  • Access to the comments section

Membership Pricing:

  • Founding member rate: $59/year (available through Dec. 31, 2025)
  • Standard membership: $79/year (beginning Jan. 1, 2026)

Food Safety News publishes more than 80 percent breaking news, recalls, and investigative reporting, providing an average of 15 to 20 original articles weekly covering emerging foodborne pathogens, regulatory changes, and food safety innovations.

Strong Reader Demand Validates Transition
The membership transition is grounded in extensive reader research. A comprehensive survey of 1,800+ readers revealed compelling support for the nonprofit model:

  • 89 percent of readers identified FSN as critical to their work
  • 67 percent indicated willingness to pay for membership access
  • More than 50 percent of respondents work in food safety professions or food industry leadership
  • Average reader engagement: readers visit the site 2 to 3 times weekly

"Our survey of 1,800+ readers showed strong demand: 89 percent said FSN is critical to their work, and 67 percent said they'd pay for it," said Peter Gustafson, Executive Director. "This membership model is built on the needs of our readers and the greater food safety community. It ensures FSN can serve them sustainably and maintain the independence that makes our work possible."

Industry Support and Testimonials
Food Safety News has earned trust among the most influential voices in food safety. Industry leaders including former FDA Deputy Commissioners Mike Taylor and Frank Yiannas have praised the publication's role in advancing food safety conversation and keeping professionals informed of critical developments. Current subscribers highlight the publication's value in their daily operations:

"FSN is indispensable to the food safety community. It keeps me in touch with worldwide food safety developments," noted one Division Quality Manager at a major international food company.

Another subscriber emphasized: "Food Safety News facilitates a bigger conversation on the importance of food safety," reflecting the publication's role in elevating industry-wide awareness.

These testimonials underscore the publication's established authority and the genuine need it fills within the food safety sector.

Sustainable Model for Independent Journalism
Food Safety News remains committed to delivering comprehensive, independent coverage of outbreaks, recalls, regulatory changes, and innovative developments in food safety policies and practices worldwide. The nonprofit status enables the organization to diversify its funding model while maintaining editorial independence.

"For 16 years, I've personally funded Food Safety News because someone needs to watch," said Bill Marler, founder and publisher. "But personal funding isn't sustainable. This transition ensures FSN outlasts me and keeps independent food safety journalism alive for decades."

Tax-deductible donations are also available to support FSN's journalism and ensure the continued publication of critical food safety coverage.

About Food Safety News
Food Safety News is an independent nonprofit publication dedicated to investigative reporting on foodborne illness outbreaks, food recalls, and regulatory developments affecting the global food supply. Founded in 2009, FSN serves food safety professionals, industry leaders, policymakers, and consumers with breaking news and in-depth analysis.

Mission: Food Safety News advances public health by delivering timely, accurate, and comprehensive coverage of foodborne illness outbreaks, recalls, and regulatory developments that impact the safety of our global food supply.

Vision: We envision a world where everyone has access to reliable food safety information, empowering consumers and industry professionals to make informed decisions that protect public health and strengthen the global food system.

The publication maintains a commitment to independent journalism without dependence on advertising, sponsorships, or corporate funding, ensuring editorial integrity and reader trust remain at the core of all reporting.

For more information, visit foodsafetynews.com. To subscribe to FSN+, visit foodsafetynews.com/membership.

Contact Name: Peter Gustafson, Fractional Executive Director, Food Safety News
Contact Email: pgustafson@foodsafetynews.com
Website: foodsafetynews.com
Follow FSN: @FoodSafetyNews on all major social platforms

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