The FDA said it investigated two foreign factories manufacturing Nara Organics infant formula linked to outbreaks of botulism. The agency found deficiencies at both plants.
The Food and Drug Administration (FDA) did not name the company or report in which country it is located. However, the FDA reports that the defects observed at the plant prompted the company to take action and are currently under review.
The FDA investigation was conducted before the agency learned of the outbreak, according to a statement issued after regular business hours Friday evening.
Nara Organic officials continue to refuse to report the infant formula manufacturer.
However, the German company Milchwerke Mittelelbe GmbH, also known by the brand name Elb-Milch, a subsidiary of the Krüger Group, appears to be the manufacturer of Nara Organics infant formula, according to the company’s website.
The whole milk powder used to produce Nara infant formula is made from milk supplied by Organic West Milk and spray dried by Dairy Farmers of America.
“These suppliers are the same suppliers of organic whole milk and organic whole milk formula following an outbreak of infant botulism associated with ByHeart infant formula formula in November 2025, but there is currently insufficient evidence to determine whether this was the source or source of contamination,” according to the FDA.
“FDA also conducted a follow-up investigation to determine whether Organic West Milk supplied milk to other powdered infant formula manufacturers during the 2025 outbreak. At that time, Organic West Milk provided an incomplete customer list that did not indicate that its milk was supplied to the Nara Organics infant formula manufacturer. As part of the current investigation, Organic West Milk notified FDA that the customer information it previously provided was incomplete and should have included Nara Organics’ suppliers.”
Officials in both states collected leftover infant formula for testing. The FDA collected unopened samples from the lot numbers supplied to the affected infants for testing. This testing is ongoing and results are expected in the coming weeks.
As of June 16, the outbreak has infected three babies in California, Pennsylvania, and Washington. All three babies required hospitalization, but none died.
In November 2025, a botulism outbreak sickened 48 babies in 17 states. The outbreak has been traced to ByHeart infant formula. Similar to the current outbreak involving the Nara Organics formula, the ByHeart formula is made with milk sourced from Organic West Milk and spray-dried by Dairy Farmers of America.
