FDA Warns Major Retailers Over Sale of Recalled ByHeart Infant Formula
The FDA has issued warning letters to Walmart, Target, Kroger, and Albertsons for continuing to sell ByHeart infant formula after a recall due to a botulism outbreak affecting 51 infants across 19 states.
The U.S. Food and Drug Administration (FDA) has issued warning letters to four major retailers—Walmart, Target, Kroger, and Albertsons—for continuing to sell ByHeart infant formula after it was recalled due to a botulism outbreak. The recall, initiated on November 11, 2025, was expanded to include all ByHeart Whole Nutrition Infant Formula products after 51 infants across 19 states were diagnosed with infant botulism. Despite being notified of the recall, the FDA found that the retailers continued to offer the recalled formula for sale. For instance, Target stores in 20 states had the product available well after the recall was initiated, and a store in New Hampshire sold the formula on November 16, despite an electronic block on the product's sales code. The FDA has given the retailers 15 working days to respond with corrective actions to prevent future violations. Failure to comply may result in legal action, including product seizures.