Organic West Milk, the supplier of whole organic milk to ByHeart and to Nara Organics, provided the FDA with an incomplete customer list during the agency’s investigation of the ByHeart botulism investigation, according to an FDA Outbreak Investigation update released on June 26, 2026.

By doing so, Organic West hid the fact that it had supplied milk to a second infant formula manufacturer. By this sin of omission, Organic West put additional infants at risk of contracting infant botulism.

The unpasteurized whole milk was shipped from Organic West Milk, a California-based company, to Dairy Farmers of America’s Fallon, Nevada facility (DFA) for pasteurization and spray-drying.

The FDA has not revealed whether or not it had also requested a customer list from DFA. Nor has it stated whether any other infant formula manufacturers were listed as customers either of Organic West or DFA.

Outbreak update

As of the June 26, 2026 update from the CDC, three babies have been stricken with infant botulism after consuming Nara Organics Whole Milk Organic Infant Formula.

The affected infants live in California, Pennsylvania, and Washington. All three were hospitalized, and have been treated with BabyBIG antitoxin supplied by the State of California. All three are expected to survive.

The infants were between 2 and 5 months of age at the time they began to develop symptoms. All three are male. The three babies became ill on April 20, May 20, and May 31, 2026.

Three different production lots of Nara Organics powdered formula were identified as having been fed to the babies: 709125280E14F2, 709125288E14F2, and 708125174E14F2.

On June 13, 2026, Nara Organics recalled “…all cans of Nara Organics infant formula currently available in the U.S.”

Outbreak investigation status

Officials in two of the three states where illnesses were reported have collected leftover infant formula to test for Clostridium botulinum. The FDA has obtained unopened samples of the three lots consumed by the affected babies and is in the process of testing those samples.

Prior to learning of the outbreak, the FDA already had conducted inspections at Milchwerke Mittelelbe GmbH and Advanced Nordic Nutrition, the two European companies involved in the manufacture and packaging of Nara Organics powdered formula.

Those inspections resulted in the identification of “deficiencies” which the companies are in the process of correcting.

Where was the contaminated formula made?

Based on US customs records, Nara Organics has received only one shipment of powdered infant formula from its European suppliers. That shipment arrived on April 30, 2026. There is no record of the company having received a shipment from any other off-shore location prior to that date.

It is evident from an examination of the illness dates that the European shipment could not possibly have been the source of the earliest illness, which developed ten days before Nara received the shipment. It is also highly unlikely, given the long incubation period often associated with infant botulism, that the other two victims had been fed the European batch.

One can only conclude that the formula fed to the three infants was produced somewhere in the USA.

The question is, “WHERE?”

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.