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 involving three confirmed cases of infant botulism in 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. The FDA has collected unopened samples from the lot numbers that were fed to the affected infants for testing. This testing is underway, and results are expected in the coming weeks. Before learning of the illnesses, the FDA 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 the FDA, which are currently under review. FDA is also 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. Interestingly, these are the same suppliers of organic whole milk and organic whole milk powder linked to the outbreak of infant botulism from ByHeart Powdered Infant Formula in November 2025. Currently, there is insufficient evidence to determine whether these suppliers are the source or the route of contamination. Further, the FDA conducted a trace-forward investigation during the 2025 outbreak to determine whether 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 the FDA that the previously provided customer information was incomplete and should have included Nara Organics as a supplier. Currently, no Nara product has yet tested positive for Clostridium botulinum. @ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026?utm_medium=email&utm_source=govdelivery
