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.
June 13, 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 three confirmed or suspected infant botulism illnesses from three states: California, Pennsylvania, and Washington. The CDPH IBTPP reported three toxin type A infections among infants consuming Nara Organics Whole Milk Organic Powdered Infant Formula with illness onset between April and May 2026. All three cases included in this outbreak consumed Nara Organics-brand powdered infant formula. Officials in two states have collected leftover infant formula for testing. This testing is underway, and results are expected in the coming weeks.
FDA contacted the firm and recommended that the firm conduct a recall due to the severity of illness and the epidemiological signal. On June 13, 2026, Nara Organics agreed to recall all of their Nara Organics brand Whole Milk Organic Powdered Infant Formula. All of Nara Organics formula was manufactured in Europe. Consumers should not use recalled infant formula.
FDA’s investigation is ongoing. 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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