The U.S. Food and Drug Administration (FDA) has issued warning letters to Walmart, Target, Kroger, and Albertsons. These letters address the retailers' continued sale of ByHeart infant formula following a recall related to a botulism outbreak. The outbreak has affected over 50 infants in 19 states.
Recall and Sales Information
The recall for all ByHeart infant formula products was initiated on November 11. Despite this, the FDA reported that the formula remained available for purchase in various stores.
- Target: Formula was observed in stores across 20 states after the recall. Specific incidents included a sale in a New Hampshire store on November 16, despite an electronic sales block, and promotional sales in an Arkansas store from November 16 to November 22.
- Walmart: Sales were documented in stores across 21 states between November 12 and November 26.
- Albertsons: Formula was found in stores across 11 states from November 12 to November 19.
- Kroger: Sales occurred in stores across 10 states between November 12 and November 19.
Regulatory Actions and Responses
The FDA indicated that the companies did not provide evidence of corrective actions despite multiple requests. The warning letters, dated December 12 and posted publicly on Monday, grant the retailers 15 working days to respond.
- Walmart: A company spokesperson stated that a sales restriction was issued and the product was removed from all impacted stores, clubs, and online platforms, adding that the company would respond to the FDA letter.
- Albertsons: The company stated it collaborated with suppliers and regulators to identify and remove the products and communicate with customers, confirming the removal of ByHeart infant formula from its shelves.
Botulism Outbreak Context
All infants affected by the botulism outbreak have been hospitalized and received intravenous medication. The U.S. Centers for Disease Control and Prevention (CDC) expanded its investigation to include all infants treated for botulism after consuming ByHeart formula since its production began in 2023.
Steven Mandernach, Executive Director of the Association of Food and Drug Officials, commented on the FDA's communication timeline, noting that the agency fully shared product lists with state and local food safety officials on November 14. This date was nearly a week after the initial recall of two ByHeart formula lots on November 8.