November 10, 2025
1 min read
Key takeaways:
- Thirteen infants have been hospitalized for botulism linked to infant formula.
- ByHeart issued a voluntary recall of two lots of ByHeart Whole Nutrition Infant Formula that were implicated in the outbreak.
Thirteen infants in 10 states have been hospitalized for botulism type A infections that the FDA and CDC linked to a brand of infant formula.
According to an FDA alert, cases have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
ByHeart voluntarily recalled two lots of ByHeart Whole Nutrition Infant Formula linked to botulism cases in 10 states. Image: Adobe Stock.
All 13 infants were reported to have consumed ByHeart powdered infant formula between August and November of this year, the FDA said.
Over the weekend, ByHeart voluntarily recalled two lots of ByHeart Whole Nutrition Infant Formula with a “use by” date of Dec. 1, 2026, according to the CDC. The agency reported that the recalled formula accounts for about 1% of U.S. baby formula sales and that there is no concern of a formula shortage.
Botulism is a bacterial infection caused by Clostridium botulinum. According to the CDC, signs of infant botulism include poor feeding, loss of head control, difficulty swallowing and decreased facial expression.
If clinicians suspect a patient has botulism, the CDC recommends consulting with the Infant Botulism Treatment and Prevention Program through the California Department of Public Health. The program offers a 24/7 consultation hotline at (510) 231-7600. Confirmed cases should be reported to state public health departments.
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