The U.S. Food and Drug Administration (FDA) has continued to investigate a multistate outbreak of infant botulism.
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 United States, according to FDA.
FDA said that as of December 3, 2025, a total of 39 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported in 18 states.
Laboratory confirmation for some cases is ongoing, the agency said.
Illnesses started on dates ranging from August 9 to November 19, 2025. All 39 infants were hospitalised. No deaths have been reported to date, said FDA.
For 38 infants with age and 39 with sex information available, they range in age 16 to 264 days and 15 (38 percent) are female.
State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick.
Thirty-nine infants have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.
FDA continues to receive reports that recalled formula is still being found on store shelves at Walmart, Target, Kroger, Acme, and Shaws, despite the ongoing recall of all ByHeart infant formula products.
FDA continues to work with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country.
All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online, said FDA.
Additional testing by ByHeart, FDA, CDC, and state partners is underway, and results are expected in the coming weeks.
ByHeart reported that they tested 36 samples of infant formula across three lots and five of those samples tested positive for Clostridium Botulinum Type A.
The specific lots that were tested have not been publicly reported by ByHeart. Positive sample results for finished product testing will be included and updated in the Sample Result section of the Advisory, said FDA.
FDA's investigation is ongoing to determine the point of contamination. This Advisory will be updated as information becomes available.
SOURCE: U.S. FDA
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