Botulism Cases in Babies Have Been Linked to Infant Formula

Clinical Takeaway: This ongoing U.S. outbreak is now responsible for 23 cases in 13 states.

Context

CDC and other agencies are investigating multiple cases of type A infant botulism across 13 states. Cases were linked to specific lots of ByHeart Whole Nutrition Infant Formula — and ByHeart formula has been recalled. All 23 infants (age range, 2 weeks–6½ months) identified since mid-August of 2025 have been hospitalized and treated with BabyBIG human immune globulin.

Infant botulism is the most common form of botulism reported in the United States. The condition is caused by ingestion of Clostridium botulinum spores that colonize the infant’s large intestine and produce botulinum neurotoxin, causing the classic symptoms (poor feeding [weak suck], ptosis, weak cry, and constipation). With disease progression, babies may develop respir…

Reviewing Author

Deborah Lehman, M.D.

Disclosures

Nothing to disclose

Deborah Lehman, M.D.

Disclosures

Nothing to disclose

Botulism Cases in Babies Have Been Linked to Infant Formula

Topics

Clinical Takeaway: This ongoing U.S. outbreak is now responsible for 23 cases in 13 states.

Context

Reviewing Author