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

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