Target, Walmart Get FDA Warning for Selling Recalled Baby Formula

Target Corp., Walmart Inc. and other large grocery chains were warned by U.S. regulators for continuing to sell ByHeart infant formula that’s been recalled because it’s potentially contaminated with spores that cause botulism.

The Food and Drug Administration on Monday released the letters dated Dec. 12 that direct the stores to improve their efforts to clear shelves of the recalled products that have been tied to infant botulism. ByHeart first recalled some formula on Nov. 8, and expanded the recall to all of its inventory on Nov. 11. According to the Centers for Disease Control and Prevention, 51 babies given the ByHeart formula have been hospitalized for botulism. None have died.

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In its letter to Target, the agency said state officials in Arkansas reported finding ByHeart formula on sale for $2 off on Nov. 20. Despite the recall, the formula remained available in Target stores across 20 states, the FDA said.

“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,” the FDA wrote in its letter.

Target and the other retailers didn’t immediately respond to requests for comment.

Related: ByHeart Botulism Outbreak May Date Back Two Years, CDC Says

The agency said it held a call with Target Nov. 19 “to discuss the ineffectiveness of the recall within your Target stores” and to ask for a detailed plan to ensure the company wouldn’t sell any more recalled formula.

“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,” the agency wrote.

The FDA also chided Walmart, The Kroger Co. and Albertsons Companies Inc. for failing to answer its follow-up emails with plans.

The letters give the companies 15 working days to respond with plans.

“Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction,” the FDA wrote.