Contributor: Aaron Lessen, MD

Educational Pearls:

A 2025 multistate outbreak of infant botulism has been linked to ByHeart infant formula

• As of December 10-17th, there have been at least 51 infants with suspected or confirmed botulism who were exposed to this formula across 19 states

• All reported cases resulted in hospitalization but no deaths reported to date

Infant botulism

•  Occurs when C. botulinum spores germinate in the infant's intestine, producing toxin

• Spores are classically found in honey but can also be in dirt or contaminated in infant formula

• Infants are particularly susceptible because their body can't neutralize the spores

• Symptoms may include initial constipation, poor feeding, weak cry, floppy movements, loss of head control, difficulty swallowing, generalized weakness, and respiratory compromise if progressive

• Can be treated with antitoxin 

• Maintain a high index of suspicion for infant botulism in infants fed the recalled formula presenting with neuromuscular symptoms. 

References

1. Human Foods Program. Outbreak Investigation of Infant Botulism: Infant Formula. U.S. Food and Drug Administration. Published 2025. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025

Summarized by Meg Joyce, MS2 | Edited by Meg Joyce & Jeffrey Olson, MS4

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