The FDA and CDC, in collaboration with state and local partners, continue investigating a multistate outbreak of infant botulism, which has now sickened nearly two dozen children, including one case in Kentucky.

Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

As of November 14, 2025, a total of 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 13 states (see map). Laboratory confirmation for some cases is ongoing.

For 22 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 1

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