ByHeart Formula Recalled Nationwide Over Botulism Cases

A nationwide recall of all ByHeart infant formula products has been issued after at least 23 infants in 13 states developed confirmed or suspected cases of infant botulism linked to the contaminated formula, federal health officials reported. The outbreak, which began in August and includes illnesses reported as recently as November 11, has led to the hospitalization of all affected babies, though no deaths have occurred. ByHeart, a New York-based manufacturer of organic formula, expanded its voluntary recall on November 11 to cover all unexpired cans and single-serve packets sold at major retailers and online.

The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are investigating the cluster of cases, which disproportionately involve ByHeart products despite the brand representing less than 1 percent of the U.S. infant formula market. California officials confirmed that a sample from an open can of ByHeart formula fed to one ill infant tested positive for Clostridium botulinum, the bacterium responsible for producing the botulinum toxin. However, tests on unopened ByHeart products have not detected the bacteria, and company officials noted that...