FDA Human Foods Program
The following is an update from FDA of concern to our subscribers.
Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
Do not use Nara Organics Whole Milk Organic Powdered Infant Formula. FDA’s Investigation is ongoing.
July 6, 2026
The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of four cases of infant botulism illnesses from three states: California, Pennsylvania, and Washington. The CDPH IBTPP reported four infants with confirmed infant botulism, with illness onset between April and May 2026. All four infants included in this outbreak consumed Nara Organics Whole Milk Organic Powdered Infant Formula.
FDA has collected unopened samples from the lot numbers fed to the affected infants for testing. This testing is underway, and results are expected in the coming weeks.
State officials have also collected infant formula from families of sick infants for testing. CDPH is one of the laboratories performing testing of opened cans of formula associated with outbreak cases. CDPH detected Clostridium botulinum in an opened can of Nara Organics powdered infant formula obtained from the home of one of the infants who got sick in this outbreak. Analyses are being conducted in addition to FDA’s analysis of the unopened sample from the same lot.
FDA continues to work with the firms included in this investigation to determine the root cause of this outbreak and if any additional products are impacted. This advisory will be updated as information becomes available. For more information about FDA’s ongoing efforts to ensure the safety of infant formula please see FDA’s Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.
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