A rare and serious outbreak of infant botulism has led to a voluntary recall of specific batches of ByHeart Whole Nutrition Infant Formula , following an investigation by federal health agencies. The outbreak has resulted in the hospitalization of 13 infants across ten states, though no deaths have been reported.

This developing situation is notable because, if confirmed, it would mark an unprecedented event in the U.S., as there is no historical precedent of infant formula causing botulism, according to a statement from ByHeart in their recall notice. Health officials and the company have stressed the importance of immediate action for parents and caregivers who may have the affected batches in their homes.

The Scope of the Outbreak

As of November 8, 2025, public health officials have

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