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Multistate Infant Botulism Outbreak Associated with Powdered Infant Formula

Connie H Chung1, Jason R Barash2, Jacquelin L Castonguay1

  • 1Infant Botulism Treatment and Prevention Program, Infectious Diseases Laboratories Division, Center for Laboratory Sciences, California Department of Public Health, Richmond, CA, USA.

NEJM Evidence
|February 25, 2026
PubMed

Insights

An infant botulism outbreak in the United States was linked to ByHeart powdered infant formula. This led to a nationwide recall of the product after 51 cases were identified.

Area of Science:

  • Public Health
  • Microbiology
  • Epidemiology

Background:

  • Infant botulism is a rare but serious illness caused by Clostridium botulinum spores.
  • Powdered infant formula has been previously identified as a potential source of infant botulism.

Purpose of the Study:

  • To identify the source of an outbreak of infant botulism.
  • To investigate the association between Clostridium botulinum type A and powdered infant formula.

Main Methods:

  • Case finding through the Infant Botulism Treatment and Prevention Program, California Department of Public Health (IBTPP-CDPH).
  • Laboratory analysis of powdered infant formula samples.
  • Epidemiological investigation to determine exposure history.

Main Results:

  • Clostridium botulinum type A was identified in ByHeart powdered infant formula.
  • A common exposure to ByHeart powdered infant formula was noted among affected neonates.
  • As of December 10, 2025, 51 cases of infant botulism linked to this formula were reported across 19 states.

Conclusions:

  • Powdered infant formula can be a vehicle for Clostridium botulinum transmission.
  • Prompt identification and public health intervention, including product recall, are crucial in managing outbreaks.
  • Continued surveillance and research are necessary to prevent future infant botulism cases associated with infant nutrition products.

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