Washington DC: The US Food and Drug Administration (FDA) has issued warning letters to four major retail chains for continuing to sell baby formula linked to a nationwide outbreak of bacterial illness in infants, despite the products having been recalled, according to information published on the regulator’s website.
The retailers named in the letters, Walmart, Target, Kroger, and Albertsons, were found to have kept recalled ByHeart Whole Nutrition Infant Formula on store shelves even after being notified of the recall in November. The FDA letters are dated December 12.
Nationwide outbreak caused
The illness associated with the recalled formula is infant botulism, a rare but serious condition that occurs when infants ingest spores of the bacterium Clostridium botulinum. These spores can grow in babies’ underdeveloped digestive systems and release toxins. Symptoms include constipation, difficulty feeding, loss of head control, and trouble swallowing, while severe cases may lead to breathing complications.
According to the US Centers for Disease Control and Prevention (CDC), the outbreak has affected 51 infants across 19 states as of last week. The affected children ranged in age from approximately two weeks to nearly nine months.
ByHeart initially recalled specific batches of its infant formula last month, before expanding the recall three days later to include all of its infant formula products. The recall applies to both traditional cans and single-serve stick packs.
FDA inspections found recalled products still available at Walmart stores in 21 states. In Target’s case, the regulator said that officials in Arkansas discovered the company had offered a $2 discount on the recalled formula between November 16 and November 22, with the product remaining available in stores across 20 states.
According to the FDA, store employees cited several reasons for the failure to remove the recalled items, including lack of awareness of the recall, confusion over which products were affected, and incomplete removal of impacted stock.
The FDA has given the retailers 15 working days to respond and outline the corrective actions taken to prevent similar violations in the future. The agency warned that failure to adequately address the issue could lead to enforcement measures, including legal action and product seizures.
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