The U.S. Food and Drug Administration (FDA) has issued warning letters to four prominent retail chains—Walmart, Target, Kroger, and Albertsons—for their alleged failure to promptly remove recalled ByHeart infant formula from store shelves. These letters, dated December 12 and publicly posted on Monday, address the continued sale of the product following an expanded recall initiated on November 11.
Recall Background
The ByHeart infant formula was recalled due to its connection with a botulism outbreak. This outbreak has resulted in the hospitalization of over 50 infants across 19 states; all affected infants received intravenous medication as part of their treatment. The U.S. Centers for Disease Control and Prevention (CDC) expanded its investigation to include all infants treated for botulism who had consumed ByHeart formula since its production began in 2023. An earlier, partial recall of two specific ByHeart formula lots had occurred on November 8.
Retailer Compliance Observations
The FDA reported that the aforementioned retailers allegedly continued to sell the recalled infant formula for periods ranging from days to weeks subsequent to the comprehensive recall on November 11.
- Target: Reports indicated the formula was present in Target stores across 20 states "well after the recall was initiated." Specific examples included a sale in New Hampshire on November 16, despite an electronic sales block, and promotional offers (a "Sale!" sign and $2 discount) for single-serve packs in an Arkansas store between November 16 and November 22.
- Walmart: Information from state and local health officials documented the presence of ByHeart formula in Walmart stores across 21 states from November 12 to November 26.
- Albertsons: The formula was reportedly found in Albertsons stores in 11 states between November 12 and November 19.
- Kroger: ByHeart formula was identified in Kroger stores in 10 states during the period of November 12 to November 19.
Agency Requests and Corporate Responses
According to the FDA, the companies failed to provide evidence of implemented corrective actions, despite multiple requests from the agency. The retailers have been allotted 15 working days to submit their responses to the warning letters.
- Walmart released a statement asserting that no ByHeart formula was sold after cash registers were blocked following the recall. A company spokesperson stated, "We moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online," also confirming their intent to respond to the letter.
- Albertsons officials communicated that the company collaborated with suppliers and regulators to identify and remove products and inform customers, adding that "ByHeart infant formula products have been removed from our store shelves."
Concerns Regarding Information Distribution
Steven Mandernach, Executive Director of the Association of Food and Drug Officials (AFDO), commented on the FDA's pace in distributing recall information to state and local food safety officials. Full product lists were not shared until November 14, nearly a week after the initial recall of two lots on November 8. Mandernach expressed concern regarding the perceived absence of urgency in ensuring the product's removal from the market, particularly given its function as a primary source of nutrition for vulnerable infants.