ByHeart Recall: FDA Steps Up Formula Testing After Infant Botulism OutbreakThe U.S. Food and Drug Administration (FDA) announced increased testing on baby formulas for contaminants, including heavy metals, following a recall of ByHearts organic infant formula due to an outbreak of infant botulism. At least fifteen infants across twelve states have fallen ill, with symptoms appearing between August and November. Infant botulism is a serious disease that can cause paralysis and death, as the bacteria produce a toxin in the large intestine, and infants underdeveloped gut microbiomes make them vulnerable. The outbreak has affected babies aged two weeks to five months, with California health officials confirming the specific bacteria linked to the outbreak in an open can of ByHeart formula. ByHeart has recalled the affected batches and offered to replace them at no cost. While this recall is concerning, it is unlikely to cause a widespread formula shortage, unlike the crisis in 2021 and 2022.

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