Outbreak Investigation
Nara Organics Infant Formula Connected to Three Infant Botulism Infant Illnesses
The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), in collaboration with the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP) and state and local partners, are investigating three infant botulism illnesses in California, Pennsylvania, and Washington.
The IBTPP reported three toxin type A infections among infants who had consumed Nara Organics Whole Milk Organic Powdered Infant Formula. Illness onset occurred in April and May. All three cases included in this outbreak consumed Nara Organics-brand powdered infant formula. No deaths have been reported.
Officials in two states have collected leftover infant formula for testing. This testing is underway, and results are expected in the coming weeks.
The FDA contacted Nara Organics on June 12 to notify it about the outbreak and recommended that the company conduct a recall due to the severity of illness and the epidemiological signal. On June 13, Nara Organics agreed to recall all of its Whole Milk Organic Powdered Infant Formula on the market. All of Nara Organics' formula was manufactured in Europe.
Nara Organics Powdered Infant Formula was distributed nationally across Target retail stores, Target.com and Nara.com between July 2025 and June 2026. Nara Organics infant formula is not distributed outside of the U.S.
“We sincerely apologize for the concern and distress this announcement causes our customers,” Nara Organics said. “We are committed to leading with transparency and accountability throughout this process as we work to identify further information.”
This recall follows a 2025 multistate outbreak of infant botulism connected to ByHeart powdered infant formula. Nearly two dozen illnesses were reported across 10 states.
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