"As of Wednesday, the Food and Drug Administration (FDA) said, 31 cases of suspected or confirmed infant botulism have been reported in babies who consumed ByHeart Whole Nutrition formula and got sick between August and mid-November. No deaths have been reported. But all 31 babies were hospitalized with the illness, which can cause a potentially life-threatening form of gradual paralysis in infants less than a year old."
"ByHeart, which describes itself as a "next-generation baby nutrition company," first hit the market in 2022. The FDA says its products make up "approximately 1%" of all infant formula sold in the U.S., so it does not have concerns about a potential shortage. In an apology note to parents, ByHeart says it is cooperating with the FDA and "investigating every facet of our process" to identify the cause of the outbreak."
"In the meantime, the company along with the FDA is urging adults to stop using the formula and monitor their babies for symptoms of botulism. The FDA is also asking stores to stop selling the product. But in its Wednesday update, the agency said it had "received reports that recalled formula is still being found on store shelves in multiple states.""
Thirty-one suspected or confirmed cases of infant botulism have been reported in babies who consumed ByHeart Whole Nutrition formula between August and mid-November; all affected infants were hospitalized and no deaths have been reported. The FDA indicates epidemiologic and laboratory data suggest contamination with Clostridium botulinum. ByHeart initially recalled two batches and then expanded the recall to all products, including cans and single-serve packets sold at major retailers and online, with some shipments outside the U.S. ByHeart products represent about 1% of U.S. infant formula sales. Caregivers are urged to stop using the formula and monitor infants; reports indicate recalled product remains on store shelves.
Read at www.npr.org
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