On December 12, 2025, the FDA sent warning letters to Walmart, Target, Kroger and Albertsons after investigators discovered recalled infant formula still available for purchase weeks after the recall was announced. FDA checks, including more than 4,000 retail visits, found the recalled product on shelves across dozens of states despite repeated notifications. The agency emphasized that retailers are legally responsible for ensuring recalled products are removed swiftly and thoroughly.
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Details of the Recall and Infant Health Risks
Baby formulaTowfiqu ahamed barbhuiya / Shutterstock
ByHeart Inc. initiated a voluntary recall on November 8, 2025, which was expanded on November 11, 2025, to cover all unexpired lots. FDA investigators found that recalled formula remained on shelves after the recall in multiple states: Walmart stores in 21 states through November 26, Target stores in 20 states, Kroger-affiliated stores in 10 states and Albertsons stores in 11 states. In one Target store, recalled single‑serve formula sticks were even promoted with a “Sale!” sign and a discount after the recall expansion.
Retailer Responses and FDA Expectations
The FDA reminded retailers that they must immediately remove recalled products and ensure they remain unavailable nationwide. Each company was given 15 working days to respond to the warning letters with specific steps to correct violations or explain why they believe they are not in violation.
The FDA emphasized that food safety is a shared responsibility across the supply chain. Swift and thorough removal of recalled products is critical to prevent further infant illnesses and ensure public trust in the safety of infant nutrition products.
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