Two companies involved in the production of powdered milk used by ByHeart in its production of infant formula tied to a botulism outbreak have been named by the Associated Press.
ByHeart’s formula has sickened 51 babies in 19 states in the outbreak, which began in December 2023. The vast majority of patients have become ill since August 2025.
This past week the Food and Drug Administration reported it had identified a producer of powdered milk as the likely source of the botulism.
On Jan. 26 an FDA spokesperson told Food Safety News that the agency would not name the producer because its investigation is ongoing. The spokesperson also said the agency would not say whether the implicated powdered milk was used by any other formula producers.
The FDA spokesperson confirmed that the outbreak strain of botulism had been found in a sample of organic powdered milk that was used in the production of ByHeart’s infant formula powder. ByHeart recalled all of its formula in November 2025.
The organic whole milk powder that tested positive for botulism was made from milk provided by Organic West Milk Inc., a California company, and processed at a Dairy Farmers of America plant in Fallon, NV, company officials told the AP.
Bill Van Ryn, an owner of Organic West Milk, told ABC News he learned last week that a sample of his company’s milk powder collected by the FDA had tested positive for the germ that causes botulism. But that doesn’t mean his product is the source of the outbreak, Van Ryn stressed.
“Nothing has been proven about our milk yet,” he said. “Something happened in the process of converting the milk to powder and then in converting it to baby formula.”
Organic West, which supplies milk from 55 farmers, didn’t sell organic whole milk powder to any infant formula maker besides ByHeart, Van Ryn said. The milk company has halted sales of the powder used in any product intended for babies and children until more is known about the source of the outbreak, he added.
The Dairy Farmers of America is a global dairy cooperative. Its plant in Nevada processes about 1.5 million pounds of raw milk daily into 250,000 pounds of whole milk powder. The group said in a statement that Organic West was the source of milk for the sample that FDA collected that tested positive for botulism bacteria. The milk was processed into powder that met all required tests, the company said. Organic West subsequently sold the milk powder to ByHeart.
