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Nearly 40 infants in 18 states were hospitalized with botulism from contaminated ByHeart formula, prompting a recall.
Nearly 40 infants across 18 states have been hospitalized with infant botulism linked to contaminated ByHeart powdered formula, the FDA confirms.
Cases, occurring from August 9 to November 19, involve babies aged 2 weeks to 9 months, with no deaths reported.
The FDA found toxin-producing bacteria in an open can and has recalled all ByHeart products, though some remain on shelves at major retailers.
The outbreak is the first known instance tied to powdered formula, with symptoms appearing up to 30 days after consumption.
Treatment requires BabyBIG, a rare antibody therapy.
ByHeart, a small-market brand, has faced lawsuits, but the FDA says the recall poses minimal risk to national formula supplies.
Casi 40 bebés en 18 estados fueron hospitalizados con botulismo debido a la fórmula contaminada de ByHeart, lo que provocó un retiro del mercado.