A multistate outbreak of infant botulism has been identified in the United States linked to ByHeart powdered infant formula. As of November 11, 2025, this outbreak includes fifteen (15) infants with suspected or confirmed infant botulism from 12 states (Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington). All 15 infants were hospitalized and treated with BabyBIG® (Botulism Immune Globulin Intravenous medication). No deaths have been reported.
Recommendations for Clinicians & Public Health Partners
Consider infant botulism a clinical diagnosis in any infant presenting with unexplained weakness, poor feeding, decreased head control, or difficulty swallowing — especially if the infant has consumed ByHeart formula.
Immediate actions when suspecting a case:
- Do not wait for laboratory confirmation to initiate case management. Early recognition and treatment are critical.
- Arrange for consultation with the
Infant Botulism Treatment & Prevention Program (IBTPP) at 510-231-7600 for evaluation and treatment guidance. Consultation is available 24 hours a day, 7 days a week.
- If clinical consultation supports infant botulism, begin treatment with BabyBIG® without delay. Do not wait for laboratory confirmation.
- Infant botulism is a notifiable disease. Report all suspected cases immediately to your state or
local health department.