Rare Infant Botulism Outbreak Ends

A significant outbreak of infant botulism, associated with ByHeart brand formula, has officially ended, according to the U.S. Centers for Disease Control and Prevention. The contamination sickened 48 infants, all of whom required hospitalization. Fortunately, no fatalities have been reported in connection with this rare illness.

The U.S. Food and Drug Administration and other health officials have been investigating the source of the contamination since August 2023, when an unusual rise in cases was first detected. Despite extensive testing of ingredients and finished product, the exact origin of the botulism spores in the organic, whole-milk powdered formula has not yet been identified.

ByHeart, a company based in New York, expanded its recall to all its products in early November. Investigators found 17 different strains of the bacteria in various samples, suggesting a complex contamination pathway. This particular outbreak has been described as unprecedented in size and scope, highlighting the rarity of botulism in infant formula.

Infant botulism occurs when spores contaminate an infant's intestine, leading to the production of a dangerous toxin that attacks the nervous system. Treatment typically involves an IV medication known as BabyBIG, which is exclusively sourced from California. ByHeart formula, which represented about 1% of the U.S. infant formula market, was marketed for its health benefits.