On December 15, the FDA sent “stern warning” letters to Walmart, Target, Kroger, and Albertsons following an investigation that found the continued sale of ByHeart Whole Nutrition Infant Formula.
The product has previously been linked to at least 51 confirmed or suspected cases of infant botulism across 19 U.S. states as of December 10. According to the Centers for Disease Control and Prevention, these are the first recorded cases of infant botulism associated with commercially sold formula in U.S. history.
Major retailers were notified of the initial recall on November 8. Formula manufacturer ByHeart later expanded the recall to include all of its products on November 11. The FDA accused Target of continuing to sell the recalled formula at stores in more than 20 states, including offering discounted promotional displays more than two weeks after the initial recall.
Walmart, Kroger, and Albertsons were also found to have continued selling the recalled product at their stores and affiliated locations. The FDA said the companies “failed to provide any evidence of corrective action” when questioned by investigators.
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“As part of the supply chain, retailers must act swiftly and effectively when notified of a product recall,” the FDA wrote. “Failure to do so may result in enforcement actions, including product seizure, injunctions, or more severe legal measures.”
Botulinum toxin is an extremely potent neurotoxin that can enter the body through contaminated food, open wounds, or tainted infant formula. The toxin binds to nerve endings and causes widespread muscle paralysis. Common symptoms in infants include poor feeding, constipation, weak crying, drooping eyelids, inability to hold up the head, and generalized muscle weakness, particularly in the arms, legs, and upper body. Without prompt medical treatment, respiratory paralysis can be fatal.
The CDC has urged parents to seek immediate medical attention if their child consumed any recalled products and shows symptoms consistent with botulism.
Walmart said it would respond to the FDA’s letter. Target, Kroger, and Albertsons had not responded to requests for comment at the time of publication.