Outbreak Investigation of Infant Botulism from ByHeart Infant Formula
National News - The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), in collaboration with state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data suggest that ByHeart Whole Nutrition infant formula may be contaminated with Clostridium botulinum.
As of November 10, 2025, fifteen infants with suspected or confirmed infant botulism have been reported across twelve states, to include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Kentucky, North Carolina, Texas, and Washington, after being exposed to ByHeart Whole Nutrition infant formula.
The illnesses began on dates ranging from August 9 to November 10, 2025. All fifteen infants were hospitalized, though no deaths have been reported. The affected infants range in age from 16 to 157 days.
Public health officials are interviewing caregivers about the foods infants consumed before getting sick. All fifteen identified cases were fed ByHeart Whole Nutrition powdered infant formula. Information from the Infant Botulism Treatment and Prevention Program (IBTPP) indicates that from August 1 to November 10, 2025, 84 infants nationwide received treatment for infant botulism.
Of the infants who had consumed powdered formula, over 40% had consumed the ByHeart brand. This figure is disproportionately high, as ByHeart accounts for an estimated 1% of total infant formula sales in the United States. The investigation has not identified any other infant formula brands as a risk.
As part of the investigation, leftover infant formula was collected for testing. On November 8, 2025, preliminary laboratory results from the California Department of Public Health indicated the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula. Additional testing is currently underway.
The FDA has been in contact with ByHeart and requested an expanded recall of all its infant formula products. On November 11, 2025, the company expanded its recall to include all ByHeart formula nationwide, including both cans and single-serve sticks.
The FDA's investigation is ongoing to determine the point of contamination, and this advisory will be updated as more information becomes available.
