Nara Organics initiated a voluntary recall on June 13. The U.S. Food and Drug Administration (FDA), U.S. Centers for Disease Control and Prevention (CDC), and state public health partners are still investigating the outbreak, with additional test results pending from unopened product samples.

Deficiencies Found at Nara Organics’ European Manufacturer

Nara Organics-brand infant formula products are manufactured by a German company, Milchwerke Mittelelbe GmbH (Elb-Milch), a subsidiary of the Krüger Group.

FDA reported that, prior to learning about the outbreak related to 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.

Commonality with ByHeart Formula C. botulinum Outbreak of 2025

FDA confirmed that the Nara Organics infant formula was 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, the agency said there is currently not enough evidence to determine if this ingredient supply chain is the source or route of contamination.

Milk Supplier Failed to Disclose Relevant Information to FDA

During the 2025 infant botulism outbreak involving ByHeart formula, FDA conducted a traceforward investigation 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.