The U.S. Food and Drug Administration (FDA) issued a formal warning to Walmart regarding the continued sale of recalled ByHeart infant formula. The recall began in November 2025. The formula is potentially linked to a botulism outbreak that hospitalized 51 infants.
FDA investigators and state partners found the recalled formula remained available for purchase on some store shelves, despite official recall notifications.
The warning letter, dated December 12, 2025, directs Walmart and other major retailers to enhance procedures for removing recalled products. The FDA noted that Walmart and several other retailers failed to respond to follow-up inquiries regarding their plans to address the situation.
The companies must provide a response detailing corrective steps within 15 working days.