Another Infant Botulism Outbreak Sickens Three, Nara Organics Formula Suspected Cause
A new infant botulism outbreak has affected three infants in three states (California, Pennsylvania, and Washington). All of the sickened children were fed Nara Organics Whole Milk Infant Formula. No deaths have been reported.
Similar to the infant botulism outbreak that occurred in late 2025 linked to ByHeart infant formula, the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (CDPH’s IBTPP) played a key role in the identification of the outbreak. CDPH IBTPP—which operates the only source of infant botulism treatment worldwide, BabyBIG—originally reported three Clostridium botulinum toxin type A infections among infants consuming the same infant formula with illness onset between April and May 2026.
Officials in two states have collected leftover infant formula for testing, which is now underway. Results are expected in the coming weeks.
Recall Information
On June 12, 2026, FDA contacted Nara Organics, based in New York, to notify the firm about the outbreak and recommended a recall due to the severity of illness and the epidemiological signal. On June 13, 2026, Nara Organics agreed to recall all lots of Nara Organics brand Whole Milk Organic Powdered Infant Formula. All of Nara Organics' formula was manufactured in Europe.
Affected Nara Organics Powdered Infant Formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026.
Nara will automatically refund all consumers who purchased formula from their website in May and June 2026 and submit a recall form here.
Update, June 23, 2026: It has come to light that, for a time, ByHeart Nutrition and Nara Organics shared a powdered organic milk ingredient supplier. Read more.
Additionally, new findings resulting from investigations into the ByHeart outbreak suggest that SRC enumeration, the "gold-standard" for C. botulinum detection, may not be sufficient to ensure that powdered infant formula is not contaminated. SRC enumeration was used by Nara Organics even prior to the ongoing outbreak. Read more.
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Update, June 24, 2026: ByHeart has developed a novel C. botulinum testing protocol that is reportedly 1,000 times more sensitive than SRC enumeration. Read more.
Update, June 29, 2026: According to FDA, prior to learning about the illnesses associated with Nara Organics formula, the agency conducted inspections at the two firms that manufacture the products 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 also confirmed that the Nara Organics infant formula lots linked to illnesses in the outbreak were made with milk supplied by Organic West Milk and spray dried by DFA. 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, currently there is not enough evidence to determine if this is the source or route of contamination, said the agency.
Finally, FDA conducted a traceforward investigation during the 2025 outbreak to determine if Organic West Milk supplied milk to any other powdered infant formula manufacturers. At that time, Organic West Milk provided an incomplete customer list that did not indicate that their 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.
