The U.S. Food and Drug Administration has issued warning letters to four major retailers for continuing to sell baby formula tied to a nationwide outbreak of bacterial illness in infants, even after the products were recalled.
Walmart, Target, Kroger, and Albertsons were found to have kept ByHeart Whole Nutrition Infant Formula on store shelves despite being notified of the recall in November. The recalled formula has been linked to cases of infant botulism, a rare but serious illness caused by spores of Clostridium botulinum. The bacteria can grow in a baby’s immature digestive system and release toxins, leading to symptoms such as constipation, poor feeding, loss of head control, difficulty swallowing, and, in severe cases, breathing problems.
The outbreak has affected 51 infants across 19 states, with children ranging from about two weeks to nearly nine months old. ByHeart first recalled select lots of its formula last month and expanded the recall three days later to include all its infant formula products, covering both cans and single-serve stick packs.
Recalled products were discovered in Walmart stores across 21 states. At Target, officials noted in Arkansas that the company had offered a $2 discount on the recalled formula from Nov. 16 to Nov. 22, with stores in 20 states carrying the affected products. Store employees cited reasons such as unawareness of the recall, confusion over which items were affected, and failure to remove all recalled products.
The FDA has given the retailers 15 working days to report the steps they have taken to prevent similar violations. The agency warned that failure to comply could lead to legal action, including product seizures.