Nara Organics Formula Connected to Three Infant Botulism Illnesses

Nara Organics Infant Formula — Nara Organics

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.

Prior to learning of the illnesses, the FDA says conducted inspections at the two firms that manufacture Nara Organics Whole Milk Organic Infant Formula in Europe. At the conclusion of both inspections, observations citing deficiencies were issued to both facilities. Both firms have submitted corrective action responses to FDA, which are currently under review.

FDA is also in the process of conducting a traceback investigation and has determined that the Nara Organics infant formula lots linked to illnesses in this outbreak were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. While these are the same suppliers of organic whole milk and organic whole milk powder from the outbreak of infant botulism linked to ByHeart Powdered Infant Formula in November 2025, the FDA says there is not enough evidence to determine if this is the source or route of contamination.

Further, FDA says it conducted a traceforward investigation during the 2025 outbreak to determine if Organic West Milk supplied milk to any other powdered infant formula manufacturers. The agency says Organic West Milk provided an incomplete customer list that did not indicate that its milk was supplied to manufacturers of Nara Organics infant formula. As part of the current investigation, Organic West Milk informed FDA that the customer information previously provided was incomplete and should have included suppliers to Nara Organics.

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.”