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37 Babies Sickened in Infant Formula Outbreak
27 Nov
Summary
- 37 infants sickened in botulism outbreak linked to ByHeart formula.
- ByHeart recalled all its U.S. products amid the ongoing investigation.
- Infant botulism cases have risen since August, prompting FDA scrutiny.
An outbreak of infant botulism has affected more than three dozen babies, with 37 confirmed or suspected cases linked to ByHeart brand powdered formula. Federal health officials announced the outbreak, which prompted the New York-based manufacturer to recall all its products sold in the U.S. on November 11. The illnesses, occurring between August 9 and November 19, required hospitalization for all affected infants, ranging in age from two weeks to nine months.
The Food and Drug Administration is actively investigating a surge in infant botulism cases reported since August, noting that ByHeart formula is disproportionately represented among sick infants. Lab tests confirmed contamination with the bacteria that can cause botulism in samples from the formula. FDA inspectors have visited the company's production facilities in Iowa and Oregon as part of the ongoing inquiry.
Infant botulism, caused by a toxin-producing bacterium found in spores, typically affects fewer than 200 babies annually in the U.S. Symptoms can include poor feeding, loss of head control, and breathing difficulties. The only treatment available is an IV medication called BabyBIG. Families of affected babies have filed lawsuits against ByHeart, alleging negligence and defective products.
