FDA Expands Botulism Outbreak Investigation to All ByHeart Baby Formula Products
Federal health officials have expanded an investigation into an outbreak of infant botulism linked to ByHeart baby formula. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have included all illnesses reported since ByHeart began production in March 2022. The outbreak now involves at least 51 infants across 19 states. The FDA has not ruled out the possibility that contamination might have affected all ByHeart formula products. The outbreak was initially announced on November 8, with 39 suspected or confirmed cases reported in 18 states. ByHeart, a New York-based company, recalled all its products sold in the U.S. on November 11. The company accounts for about 1% of the U.S. infant formula market. The FDA has conducted inspections at ByHeart's production facilities in Iowa and Oregon, but results have not been released. Previously, ByHeart had a history of contamination issues, including a recall in 2022 due to cronobacter sakazakii contamination. 
