FDA WARNING_LETTER - Walmart, Inc - November 26, 2025

On December 12, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Walmart, Inc., regarding serious violations related to the continued sale of recalled ByHeart Whole Nutrition Infant Formula. Beginning in November 2025, an investigation by FDA and its partners linked this formula to a multistate infant botulism outbreak, affecting 51 infants. The presence of *Clostridium botulinum* renders the product adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Despite receiving written notifications of the voluntary recall and its expansion on November 8 and November 11, 2025, regulatory visits confirmed that the recalled infant formula remained available for purchase on shelves in numerous Walmart stores across 21 states between November 12 and November 26, 2025. This constitutes a violation of section 301(c) of the FD&C Act, concerning the receipt and delivery of adulterated food in interstate commerce. Walmart store associates cited various explanations, including lack of awareness and confusion regarding the recall scope.

The FDA held a discussion with Walmart"s CEO on November 18, 2025, to address the ineffectiveness of the recall within their stores. However, despite multiple follow-up emails, Walmart has not provided information demonstrating implemented corrective actions. The FDA requires Walmart to notify the agency in writing within 15 working days, detailing specific steps taken to address violations, prevent recurrence, and provide supporting documentation. Failure to adequately respond may result in legal actions such as seizure or injunction.