DFA explained the arrangement to Food Fix, stating, “DFA does not supply whole milk powder directly to Nara Organics or any other infant formula manufacturers. A Nara supplier utilized DFA’s Fallon, Nevada, facility to process a portion of its organic milk supply into a powder ingredient. We understand that Nara purchased this ingredient from the organic supplier and combined it with ingredients from other suppliers, further processing it in its manufacturing plant into a finished infant formula product.”

‘Gold-Standard’ C. botulinum Test Failed to Stop Outbreak

Even before the current outbreak, Nara Organics highlighted its use of “gold-standard” Clostridium botulinum testing protocols recommended by the International Commission on Microbiological Specifications on Food (ICMSF)—that is, sulphite reducing clostridia (SRC) enumeration—at specifications ten times stricter than those recommended by ICMSF.

However, new findings resulting from investigations into the ByHeart outbreak suggest that SRC enumeration may not be sufficient to ensure powdered infant formula is free of C. botulinum. This suggestion is further evidenced by the fact that SRC enumeration did fail to catch contamination in Nara’s ingredients, process, or final product—making way for an outbreak.

As of June 15, 2026, three infants in three states have been hospitalized with botulism in the current outbreak. All three babies were fed Nara Organics formula.

FDA Unable to Explain C. botulinum in Powdered Milk Ingredient 

Although the U.S. Food and Drug Administration’s (FDA’s) investigation into the ByHeart outbreak did identify C. botulinum in a powdered milk ingredient, and also matched C. botulinum isolates recovered from a DFA facility to isolates from a clinical case and a finished formula product sample, FDA said it has so far been unable to identify the root cause of contamination or additional factors that could explain the outbreak. Investigation activities are still ongoing.

Until now, C. botulinum has not been considered to be a hazard reasonably likely to occur in powdered infant formula manufacturing.

The ByHeart outbreak was declared over on February 26, with 48 infants falling ill in 17 states.

Lawsuit Alleges Nara Ignored Powdered Milk Ingredient Risk

A lawsuit has been filed by Marler Clark on behalf of a Pennsylvania infant who was hospitalized with botulism after consuming Nara Organics Whole Milk Organic Powdered Infant Formula. The lawsuit alleges that Nara Organics sold its infant formula to American families at a time when the risk of C. botulinum in powdered whole milk had been documented by federal regulators and demonstrated through the very similar ByHeart outbreak—and that Nara Organics marketed the use of powdered whole milk as a premium, rather than disclosing it as a hazard.

Marler Clark cites a 2023 Call-to-Action letter issued by FDA to the infant formula industry that identified whole milk powder as a potential vehicle for C. botulinum contamination, as botulinum spores can survive ordinary pasteurization and the spray-drying used to make powdered formula. Despite this, Nara Organics marketed its product as the first and only U.S. Department of Agriculture (USDA)-Certified Organic whole-milk infant formula and that it contained more organic whole-milk fat than any other infant formula sold in the U.S., per Marler Clark. The lawsuit alleges that Nara turned the "most dangerous" feature of its product into its central marketing claim, while not disclosing the known risk of powdered whole milk to parents.

At present, three babies who were fed Nara Organics formula have contracted botulism. The company recalled its product out of an abundance of caution based on early epidemiologic evidence. Product testing for C. botulism in Nara products is still ongoing.

Update, June 24, 2026: ByHeart has developed a novel C. botulinum testing protocol that is reportedly 1,000 times more sensitive than SRC enumeration. Read more.

Update, June 29, 2026: According to FDA, prior to learning about the illnesses associated with 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.

FDA also confirmed that the Nara Organics infant formula lots linked to illnesses in the outbreak were 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, currently there is not enough evidence to determine if this is the source or route of contamination, said the agency.

Finally, 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.