The FDA has revealed that it inspected two foreign plants that manufacture Nara Organics infant formula that has been tied to an outbreak of botulism. The agency found deficiencies at both plants.
The Food and Drug Administration has not named the businesses nor reported what country they are in. However, the agency is reporting that the deficiencies observed at the plants resulted in actions by the companies, which are now under review.
The FDA inspections were conducted prior to the agency learning about the outbreak, according to a statement issued Friday evening after regular business hours.
Officials with Nara Organics continue to refuse to report the manufacturer of their infant formula.
However, a company website reveals that the German company Milchwerke Mittelelbe GmbH — also known by its brand name Elb-Milch, a subsidiary of the Krüger Group — is the manufacturer of Nara Organics infant formula.
The whole milk powder used in the production of the Nara infant formula was 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,” according to the FDA.
“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.”
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.
As of June 16, the outbreak has sickened three babies in California, Pennsylvania and Washington. All three of the babies have required hospitalization, but none have died.
In November 2025 an outbreak of botulism sickened 48 babies across 17 states. That outbreak was traced to ByHeart infant formula. As with the current outbreak linked to Nara Organics formula, the ByHeart formula was made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America.
