Baby nutrition company ByHeart is recalling all batches of its Whole Nutrition Infant Formula following a multi-state outbreak of infant botulism.

Thirteen of the 83 cases of infant botulism reported across the United States since August 2025 involved infants who had consumed ByHeart-brand powdered infant formula, according to the Food and Drug Administration (FDA). All 13 affected infants were hospitalized, with cases reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

Federal officials still haven't identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism, according to ByHeart. However, the company initiated the recall for al

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