The FDA has published an outbreak update to report a total of 31 cases of infant botulism in babies who were fed ByHeart Whole Nutrition Infant Formula as of November 19, 2025.
Infant botulism cases were reported in 15 states, including Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, but other states may have unreported cases.
The most recent illness began on November 13, which was two days after ByHeart recalled every single can of infant formula and single-serve “anywhere” sticks worldwide.
The FDA said it has “received reports that recalled formula is still being found on store shelves in multiple states.” This is concerning because all ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online.
Health officials in California also tested an opened can of ByHeart Infant Formula from the home of a baby who got botulism, and confirmed that it was contaminated with Clostridium botulinum, which is a toxin-producing bacteria that causes botulism.
The FDA is conducting further testing on unopened cans of ByHeart Infant Formula. Investigators are also trying to pinpoint the source of contamination. Test results are expected in the coming weeks.
It is difficult to test for Clostridium botulinum in powdered baby formula, and a negative test result does not rule out contamination.
As the investigation unfolds, parents who still have ByHeart Infant Formula in their home are urged to keep the formula for possible testing. According to the FDA: “Keep the container in a safe spot and be sure to label that product as DO NOT USE.”
It can take up to 30 days for babies to show symptoms of botulism. If your baby gets sick, a contaminated ByHeart Infant Formula product may be important evidence in the investigation, or a potential lawsuit.
“If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.”
Botulism can be deadly or cause severe long-term disabilities. Parents should take immediate action if a baby develops symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression.
Source: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
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