FDA investigating 10-state outbreak of botulism from infant formula

The Food and Drug Administration Nov. 8 announced it is investigating an outbreak of 13 infant botulism illnesses in 10 states. The agency said all cases were reported to have consumed ByHeart Whole Nutrition Infant Formula and is recommending parents and caregivers throw away the product if it is from lot 206VABP/251261P2 or 206VABP/251131P2, both with a use by date of Dec. 1, 2026. No deaths have been reported so far, the FDA said. Cases have been identified in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

The FDA, working in collaboration with the Centers for Disease Control and Prevention, California Department of Public Health, the Infant Botulism Treatment and Prevention Program, and state and local partners, said it is working to determine whether any other company products were impacted.

Additionally, the FDA announced Nov. 7 that three lots of injectable famotidine by Fresenius Kabi were voluntarily recalled due to out-of-specification endotoxin results of certain reserve samples.