FDA Issues Warning Letters to Major Retailers for Failure to Remove Recalled Baby Formula

FDA issued Warning Letters to major retailers for failure to properly respond to the recall of ByHeart baby formula that was linked to botulism cases in infants.  Kroger, Walmart, Albertsons and Target were issued Warning Letter stating the the retailers did not properly conduct the needed corrective actions to remove product from the store shelves in a timely manner.  This is a reminder to entire industry for the need to properly respond to recall notices.

In a notice to the industry, FDA stated that inspectors "had checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. 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."

Here are the highlights for the Warning Letter to Kroger.

• The Kroger Company (Kroger) was notified on November 8, 2025, of this voluntary recall. On November 11, 2025, ByHeart expanded the recall to all ByHeart Whole Nutrition Infant Formula, including all unexpired lots of formula cans and single-serve “anywhere pack” sticks. As a consignee of the recalled products, Kroger was notified in writing on November 11, 2025, that the scope of the voluntary recall had expanded to include all ByHeart infant formula products. Despite these recall notifications, subsequent visits by regulators confirmed that recalled ByHeart Whole Nutrition Infant Formula remained available for purchase on shelves at (b)(4) Kroger stores, including Kroger’s, King Sooper’s, and Smith’s, across 10 states well after the recall was initiated and subsequently expanded.
• 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
• 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.

Walmart, Albertsons and Target were issued similar letters with similar findings in failure to properly respond.

US Food and Drug Administration
https://content.govdelivery.com/accounts/USFDA/bulletins/4000713
FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula
U.S. Food and Drug Administration sent this bulletin at 12/15/2025 04:14 PM EST

Another Salmonella Outbreak Linked to Eggs in California

The California Dept of Health reported that 63 people have become ill with Salmonella Enteritidis infection from eggs from Vega Farms, Inc. in Dixon, CA.

According to one report, "After identifying the supplier of the suspect eggs, CDPH and CDFA conducted an inspection at Vega Farms, Inc. and collected egg and environmental samples for testing. Multiple samples tested positive for Salmonella. Whole genome sequencing analysis revealed that the Salmonella in at least one sample matched the strain found in sick individuals. Vega Farms eggs were sold to restaurants, grocery stores, co-ops, and in farmers markets in Northern California."

While no one likes to say it, Salmonella control is more difficult for operations with open range chickens.  Advise should be for cooking those eggs thoroughly.


https://www.independent.com/2025/12/12/cdph-warns-consumers-not-to-eat-recalled-vega-farms-inc-in-shell-eggs/

CDPH Warns Consumers Not to Eat Recalled Vega Farms, Inc. In-shell Eggs

By California Department of Public Health

Fri Dec 12, 2025 | 12:13pm

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FDA Provides Update on Infant Botulism Outbreak (12/10/25)

In the most recent update, CDC broadened the timeframe associated with the ByHeart product.  "CDC broadened the case definition to include any infant with botulism who was exposed to ByHeart formula at any time since the product’s release in March 2022. As of December 10, 2025, a total of 51 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 19 states."

"Previously, case counts included illnesses from August 1, 2025, onward. With the expanded definition, CDC and state partners identified 10 additional prior cases that occurred from December 2023 through July 2025. At this time, no cases have been identified between March 2022 and December 2023. All 10 prior cases are confirmed infant botulism cases with documented exposure to ByHeart formula."

"FDA’s investigation is ongoing to determine the point of contamination."

Case Counts
Total Illnesses: 51 (12 New)
Hospitalizations: 51 (12 New)
Deaths: 0
Last Illness Onset: December 1, 2025
States with Cases: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OH, OR, PA, RI, TX, VA, WA, WI
Product Distribution: Online and nationwide (including Guam and Puerto Rico), and internationally

The previous update was 12/3/25.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
Do not use recalled ByHeart Whole Nutrition Infant Formula. FDA’s investigation is ongoing.

Food Companies Push Back on Texas Law Requiring Warning Label for Certain Ingredients

Food companies are suing the State of Texas after the state's new law requiring warning labels for over 40 different ingredients.  "Section 9 of the law requires food manufacturers to include warning labels on products that include 44 listed ingredients, including artificial additives, dyes and chemicals, informing customers that governments in Australia, Canada, the European Union, or the United Kingdom have labeled the ingredients as “not recommended for human consumption.”"  Note, this is not based upon what the US has determined, but what other countries have determined.

From the Texas Rule

Sec. 431.0815.  FOOD CONTAINING ARTIFICIAL COLOR, ADDITIVES, OR CERTAIN BANNED CHEMICALS. (a) A food manufacturer shall ensure each food product the manufacturer offers for sale in this state includes a warning label disclosing the use of any of the following ingredients, if the United States Food and Drug Administration requires the ingredient to be named on a food label and the ingredient is used in a product intended for human consumption:

The warning label must:  (1)  include the following statement if the food contains an ingredient listed in Subsection (a), printed in a font size not smaller than the smallest font used to disclose other consumer information required by the United States Food and Drug Administration:

“WARNING: This product contains an ingredient that is not recommended for human consumption by the  appropriate authority in Australia, Canada, the European Union, or the United Kingdom.";

Many of these ingredients have been long used in the US and are in many of the foods we eat....well, foods I eat....you know, those highly processed foods like potato chips and snack cakes.

Here are some from the list which I knew to be readily used.

(Entire list - https://legiscan.com/TX/text/SB25/id/3247967  about half way down the webpage)

• Bleached flour is treated white flour treated creating a softer texture that absorbs more liquid, making it great for delicate cakes, cookies, and pie crusts
• BHA and BHT - synthetic antioxidants used as preservatives in foods (cereals, chips, meats, etc) to prevent fats and oils from going rancid
• Diacetyl occurs naturally and it gives butter its characteristic taste. Because of this, manufacturers of artificial butter flavoring, margarines or similar oil-based products typically add diacetyl to give that characteristic aroma/flavor.
• Potassium aluminum sulfate is a firming agent for pickles, leavening in baking, pH control
• Sodium aluminum sulfate is used in baking powder as a slow-acting leavening agent
• Sodium Lauryl Sulfate is an emulsifier/thickener in some dried eggs, marshmallows, and beverage bases
• Stearyl tartrate is an emulsifier and dough strengthener to improve dough texture
• Stearyl tartrate acts as a dough strengthener, emulsifier, and stabilizer in foods, improving consistency

To heck with the sugar in that pack of Ho-Hos, it is the dough conditioner you have to worry about.

Reuters
https://www.reuters.com/legal/government/food-industry-groups-sue-texas-over-ingredient-warning-labels-2025-12-08/
Food industry groups sue Texas over ingredient warning labels
By Dietrich Knauth

December 8, 20251:54 PM ESTUpdated December 8, 2025

NY Distributor Recalls Bangladeshi Indian Snack Mix After State Lab Detects Undeclared Peanuts

South Asian Food Inc. of Maspeth, Queens, NY is recalling its 12.34oz (350gm) packages of Bengal King Jhal Chanachur food treats because they may contain undeclared peanuts.   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.

The recalled Bengal King Jhal Chanachur were distributed nationwide in retail stores and through mail orders. 

"Chanachur or Bombay mix is a Bangladeshi Indian snack mix (namkeen) which consists of a variable mixture of spicy dried ingredients, such as fried lentils, peanuts, chickpea flour ghatia (sev), corn, vegetable oil, chickpeas, flaked rice, fried onion and curry leaves. This is all flavored with salt and a blend of spices that may include coriander and mustard seed." (Ref)


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/south-asian-food-inc-issues-allergy-alert-undeclared-peanuts-bengal-king-jhal-chanachur
South Asian Food Inc. Issues Allergy Alert on Undeclared Peanuts in "Bengal King Jhal Chanachur "
Summary
Company Announcement Date:  December 12, 2025
FDA Publish Date:  December 12, 2025
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared peanut allergen
Company Name:  South Asian Food Inc
Brand Name:  Bengal King
Product Description:  Jhal Chanachur food treats

Ohio Foodservice Establishment Recalls Mispackaged Sliders Undeclared Allergens Associated with Jalapeno Cheese

White Castle Frozen Food Division, Columbus, OH has initiated a recall of 1,021 cases of its retail frozen 4-count cartons of Original Sliders due to undeclared milk and soy. The carton may contain Jalapeño Cheese Sliders. Jalapeño Cheese Sliders contain milk and soy, allergens that are not on the Original Slider carton label.

During the packaging process, Jalapeño Cheese Sliders were put in the wrong package, and milk and soy are not listed as ingredients or allergens on the packaging. The issue was discovered when a customer notified White Castle that they suffered a non-life-threatening allergic reaction after consuming one of the Jalapeño Cheese Sliders that was incorrectly packaged in the 4-count Original Sliders carton. No other reports of injury or illness have been received to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/white-castle-frozen-food-division-recalls-frozen-4-count-cartons-original-sliders-due-undeclared
White Castle Frozen Food Division Recalls Frozen 4-Count Cartons of Original Sliders Due to Undeclared Milk and Soy
Summary
Company Announcement Date:  December 12, 2025
FDA Publish Date:  December 12, 2025
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared milk and soy allergens
Company Name:  White Castle Food Products LLC
Brand Name:  White Castle
Product Description:  Original Sliders, frozen, 4 count carton

Illinois Firm Mislabels Tamale Products Resulting in Undeclared Allergens

La Guadalupana Foods LLC, a Chicago, Ill., establishment, is recalling approximately 2,669 pounds of frozen tamale products due to misbranding and an undeclared allergens.   The bean, cheese, and jalapeno tamales were mislabeled as mild pork tamales. The bean, cheese, and jalapeno tamale product contains cheese (milk), a known allergen, which is not declared on the product label.  [Not to mention that they also contain jalapenos....a bit unexpected when one cracks open the mild variety.]

The problem was discovered when a restaurant notified the establishment that they had identified bean, cheese, and jalapeno tamales that had been mislabeled as pork tamales.  [He immediately identified them as Hot Tamales].


https://www.fsis.usda.gov/recalls-alerts/la-guadalupana-foods-llc-recalls-ready-eat-frozen-tamales-due-misbranding-and
La Guadalupana Foods LLC Recalls Ready-To-Eat Frozen Tamales Due to Misbranding and an Undeclared Allergen

FSIS Announcement

WASHINGTON, Dec. 14, 2025 – La Guadalupana Foods LLC, a Chicago, Ill., establishment, is recalling approximately 2,669 pounds of frozen tamale products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The bean, cheese, and jalapeno tamales were mislabeled as mild pork tamales. The product contains cheese (milk), a known allergen, which is not declared on the product label.

Georgia Establishment Recalls Fully Cooked Chicken Product After Mis-coding Issue Results in Undeclared Soy

Suzanna’s Kitchen, a Suwanee, Ga., establishment, is recalling approximately 62,550 pounds of fully cooked, bone-in breaded chicken products due to misbranding and an undeclared allergen - the product contains soy, a known allergen, which is not declared on the product label.  The problem was discovered when the company notified FSIS that they had identified chicken product containing soy that had been mislabeled with a non-allergen containing product code


https://www.fsis.usda.gov/recalls-alerts/suzannas-kitchen-recalls-fully-cooked-breaded-chicken-products-due-misbranding-and
Suzanna’s Kitchen Recalls Fully Cooked Breaded Chicken Products Due to Misbranding and an Undeclared Allergen

FSIS Announcement

WASHINGTON, Dec. 12, 2025 – Suzanna’s Kitchen, a Suwanee, Ga., establishment, is recalling approximately 62,550 pounds of fully cooked, bone-in breaded chicken 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 contains soy, a known allergen, which is not declared on the product label.

NJ Establishment Recalls Fresh Lamb Products Produced Without Federal Inspection

Ghanaianway Restaurant and Grocery LLC in Newark, N.J., is recalling approximately 5,970 pounds of fresh salted lamb products that were produced without the benefit of federal inspection.  The products subject to recall do not bear a USDA mark of inspection nor do they declare a best by or production date. Some packages do not bear a label at all. The affected products have a 1-year shelf life and were shipped to restaurant and retail locations in Connecticut, Maryland, Massachusetts, Minnesota, New Jersey, New York, and Pennsylvania.  The problem was discovered during routine FSIS retail surveillance activities. There have been no confirmed reports of illness due to consumption of these products.

https://www.fsis.usda.gov/recalls-alerts/ghanaianway-restaurant-and-grocery-llc-recalls-fresh-salted-lamb-products-produced
Ghanaianway Restaurant and Grocery LLC Recalls Fresh Salted Lamb Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, Dec. 9, 2025 – Ghanaianway Restaurant and Grocery LLC in Newark, N.J., is recalling approximately 5,970 pounds of fresh salted lamb products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.