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The U.S. Food and Drug Administration issued warning letters to Walmart, Target, Kroger and Albertsons for continuing to sell ByHeart infant formula weeks after a national recall announced on Nov. 11, even as the product has been linked to a botulism outbreak that has sickened more than 50 infants across 19 states.
Regulatory concerns
In letters dated Dec. 12, the FDA reminded the retailers that “as a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall.” The agency also noted that each company had failed to provide evidence of corrective measures within the 15‑day response window.
Extent of continued sales
Target stores in 20 states were found to have ByHeart formula “well after the recall was initiated,” including a New Hampshire location on Nov. 16 where an electronic block on the product’s sales code was ineffective. In Arkansas, single‑serve packs were even advertised with a $2 discount from Nov. 16 to Nov. 22.
State and local health officials reported that Walmart continued to carry the formula in 21 states from Nov. 12 to Nov. 26. Albertsons and Kroger were cited for selling the product in 11 and 10 states, respectively, during the period Nov. 12 to Nov. 19.
Company responses
Walmart said cash registers were blocked after the recall and no further sales occurred. A spokesperson added that the company “moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online.”
Albertsons claimed it worked closely with suppliers and regulators to remove the product and confirmed that “ByHeart infant formula products have been removed from our store shelves.”
All infants affected by the outbreak have been hospitalized and are receiving IV treatment to halt disease progression. The CDC has expanded the outbreak scope to include every baby treated for botulism after consuming ByHeart formula since production began in 2023.
Industry reaction
Steven Mandernach, executive director of the Association of Food and Drug Officials, called the situation “disappointing,” noting that the FDA’s delayed sharing of product lists may have contributed to the prolonged exposure.
Frequently Asked Questions
Which retailers were warned by the FDA?
The FDA sent warning letters to Walmart, Target, Kroger and Albertsons for continuing to sell ByHeart infant formula after the recall.
When was the recall of ByHeart formula announced?
The nationwide recall of all ByHeart infant formula products was announced on Nov. 11, following an initial recall of two lots on Nov. 8.
What actions have the retailers taken after the FDA’s warning?
Walmart reported that it blocked sales at cash registers and removed the product. Albertsons said it removed the formula from shelves and worked with suppliers and regulators. Target’s specific corrective actions were not detailed in the letters.
How might these developments affect the broader supply chain for infant nutrition products?
