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 26, 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 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. FDA has collected unopened samples from the lot numbers fed to the affected infants for testing. This testing is underway, and results are expected in the coming weeks.
Prior to learning of the illnesses, 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 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, currently there is not enough evidence to determine if this is the source or route of contamination.
Further, 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.
FDA continues to work with the firms included in this investigation to determine the root cause of this outbreak and if any additional products are impacted. The FDA has also been in contact with relevant European authorities. 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.
|
