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By Hollie Silverman
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The U.S. Food and Drug Administration (FDA) issued warning letters to four of America's largest retailers after finding infant formula linked to a botulism outbreak remained available for purchase well after an official recall was announced in November.
The letters were sent by the FDA to Walmart, Target, Kroger, and Albertsons, raising concerns over the availability of ByHeart infant formula.
The Context
Botulism is a potentially fatal illness, and the fact that tainted formula was not promptly removed adds urgency for systemic improvements across the retail and public health sectors.
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The Centers for Disease Control and Prevention (CDC) reported that more than 50 infants in 19 states have been hospitalized due to the outbreak.
The FDA's warning comes as families and health advocates increase calls for greater transparency and accountability during food safety crises.
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What To Know
The FDA posted its warning letters on December 12, naming Walmart, Target, Kroger, and Albertsons for failing to quickly remove ByHeart infant formula from sale after its recall on November 14. On November 20, Newsweek reported the botulism outbreak had affected 31 babies across 15 countries.
Now, the botulism outbreak has so far sickened more than 50 infants across 19 states, with all affected children requiring hospitalization and intravenous medication, according to the CDC.
The FDA said that, despite being notified of the recall, retailers continued to sell the product for days or weeks in multiple states.
The FDA found ByHeart formula for sale at Target stores in 20 states 'well after the recall was initiated,' including one New Hampshire store where it was sold on November 16 despite an electronic block on its sales code, and at an Arkansas store where single-serve packs were even promoted with a 'Sale!' sign from November 16 to November 22, the Associated Press (AP) reported.
At Walmart stores, the formula was found on shelves in 21 states from November 12 to November 26. Albertsons locations in 11 states and Kroger locations in 10 states also reportedly continued to offer ByHeart formula through at least mid-to-late November, after the recall should have been in effect.
The FDA said the named companies have not provided evidence that corrective actions were implemented, despite repeated requests.
The warning letters give each 15 working days to respond with a remedy or explanation. Failure to address the issue could potentially lead to further regulatory action, although the agency did not specify next steps publicly.
Walmart stated that once its registers were blocked from selling the formula following the recall, 'no ByHeart formula was sold.'
The CDC expanded the recall to include all babies treated for botulism after consuming ByHeart formula. Steven Mandernach, executive director of the Association of Food and Drug Officials, noted shortcomings in the FDA's own response, saying the agency did not distribute key recall information to state and local officials until November 14, nearly a week after the initial action. Mandernach said it was 'disappointing' given the product's role as a sole nutritional source for infants.
What is Infant Botulism?
Infant botulism is a rare but serious illness caused by ingestion of Clostridium botulinum spores, which produce toxins in the gut that attack the body’s nerves, causing muscle weakness. Early symptoms include constipation, difficulty swallowing, feeding difficulties, weak crying, decreased facial expression, and loss of head control, progressing to lethargy and potentially respiratory arrest.
What People Are Saying
FDA’s warning letters stated: “As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall.”
Walmart spokesperson said in an email to the Associated Press: 'We moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online ... We take all reports of inaction seriously and will respond to the letter.' Albertsons said that its stores worked closely with suppliers and regulators to identify and remove the products, adding, 'ByHeart infant formula products have been removed from our store shelves.:
An Albertsons spokesperson said in a statement to AP: “ByHeart infant formula products have been removed from our store shelves.”
What Happens Next
The four retail chains—Walmart, Target, Kroger, and Albertsons—have 15 working days from the receipt of the FDA warning letters to respond and provide documentation showing corrective action.
The FDA has not specified what further action may be taken if companies fail to comply. The agency and CDC continue to monitor the ongoing recall and associated illnesses among infants.
Additional regulatory or legal steps are possible, depending on the retailers’ responses and any further findings connected to the outbreak.
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