When a product is voluntarily recalled, federal food safety rules require every retailer to remove it immediately. But the U.S. Food and Drug Administration recently found several major retailers failing to fully comply after a recall connected to a serious infant illness outbreak. The agency’s concern centers on how recalled baby formula was handled at the retail level, highlighting gaps in recall effectiveness for vulnerable consumers.
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
The recalled product, ByHeart Whole Nutrition Infant Formula, was linked to a multistate outbreak of infant botulism. At least 51 infants in 19 states were hospitalized after consuming the formula. Infant botulism can cause constipation, poor feeding and difficulty breathing, sometimes developing weeks after exposure.
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.
The FDA stressed that selling recalled infant formula violates federal law, regardless of whether contamination is later confirmed. The agency cited store-level confusion, lack of awareness and restocking of recalled items as key failures contributing to the continued availability of unsafe products.
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.
Some retailers have reported taking corrective measures, such as blocking sales and removing products from shelves and online. However, the FDA noted that documentation showing effective nationwide action had not been provided at the time of the warning letters.
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.
Related: Recall Issued for Popular Dairy-Free Ice Cream That May Contain 'Small Stones'
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