Photo: FDA
The U.S. Food and Drug Administration (FDA) has issued warning letters to Walmart, Target, Kroger, and Albertsons for selling ByHeart infant formula linked to a botulism outbreak. Despite a recall initiated on November 11, these retailers continued to sell the product, which has been tied to over 50 infant illnesses across 19 states.
The FDA's investigation revealed that some stores kept the formula on shelves weeks after the recall. The agency communicated repeatedly with the retailers, requesting action plans to remove the product, but received no responses. FDA Commissioner Dr. Marty Makary emphasized the shared responsibility of ensuring food safety, stating, "It is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation's children from unsafe food."
ByHeart's recall affects all its Whole Nutrition Infant Formula products, which make up about 1% of the U.S. market. The outbreak, which has hospitalized all affected infants, is linked to Clostridium botulinum contamination, a bacterium that can cause severe illness in infants. Symptoms include constipation, poor feeding, and respiratory issues.
The FDA has given the retailers 15 working days to address the issue or face potential legal action. According to FDA reports, no deaths have occurred, but the investigation is ongoing. The FDA continues to work with state partners and retailers to ensure the recalled products are removed from shelves nationwide.