The U.S. Food and Drug Administration (FDA)has issued a stern warning to several major retailers, including Target and Walmart, after repeated checks revealed that recalled ByHeart infant formula products connected to a nationwide botulism outbreak were still being sold. According to NBC Chicago, 51 infants across 19 states have developed botulism, a serious illness, after consuming the formula.
In violation of safety precautions, the retailers were found to have left these recalled products on their shelves through at least November, which the FDA explicitly mentioned in the warning letters sent last Friday. Not only were these products available, in some cases, they were even promoted with a "Sale!" sign, as described by the FDA – the intended recall of the products was a stark contrast to their continued availability on store shelves. In a statement to NBC Chicago, Albertsons confirmed that "ByHeart infant formula products have been removed from store shelves," committing to customer health and safety.
ByHeart initiated the widespread recall on November 11, with all the company's Whole Nutrition Infant Formula products, including cans and Anywhere Pack single-serve sticks, pulled both online and in stores. According to the investigation updates from the Centers for Disease Control and Prevention (CDC) and the FDA, the outbreak has hospitalized infants ranging from 2 weeks to 9 months old. The FDA's sweep of over 4,000 store checks across the nation, reported by ABC News, revealed the alarming presence of recalled formula in over 175 store locations across 36 states.
Unfolding during a critical point in the investigation, retailers, as stated in the warning letters, have 15 days to respond to the FDA detailing the measures taken to rectify the situation and to prevent further violations. In response to the FDA's admonition, Walmart told ABC News, "When notified of the recall, we moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online." ByHeart president and co-founder Mia Funt has prioritized the safety and well-being of their consumers and continues to investigate the root cause extensively.
Botulism, the illness at the center of the outbreak, is rare but can be deadly, attacking the body's nerves and leading to difficulty breathing, paralysis, and even death. Babies can develop infant botulism by ingesting Clostridium botulinum spores that produce a toxin once inside the gut. The CDC emphasizes the urgency of seeking medical care for infants showing symptoms post-consumption of ByHeart products. ByHeart has offered full refunds for the recalled formula bought on their website since August 1 and directs affected customers to contact them or the retailer from where they purchased the formula for more information on refunds.
