The Centers for Disease Control and Prevention has declared the outbreak of botulism traced to Nara Organics powdered infant formula to be over.
In total, the outbreak between April and May this year sickened a confirmed four babies in three states. All four babies required hospitalization but none of them died. All four of the babies had been fed Nara Organics infant formula. The sick babies lived in California, Washington and Pennsylvania, indicating nationwide problems with the formula.
The Food and Drug Administration found the source of the spores that cause botulism poisoning from the Nara Organics product to be milk supplied by Organic West Milk and spray dried by Dairy Farms of America.
Those two companies were also found to be the source of botulism in a variety of infant formula products from ByHeart Inc. that sickened 48 babies across 19 states, mostly in 2025. All of those babies required hospitalization but none of them died. The CDC determined that some of the illnesses dated back to December 2023.
The specific cause of the contamination at Organic West Milk and Dairy Farms of America has not been reported by the FDA or CDC. Both companies issued recalls of their products.
As part of the outbreak investigations the FDA and state health departments collected samples of finished products as well as from the sick babies. The contaminate in the infant formula matched samples from the a sick baby. The contaminate from the Nara Organics product also matched that found in the ByHeart product, showing a common link to Organic West Milk and Dairy Farms of America.
However, there is currently not enough evidence to determine if milk was contaminated before drying or during the drying process, and FDA’s root cause investigation is ongoing.
Prior to reports of the sick babies associated with the Nara Organics formula, the Food and Drug Administration inspected two foreign companies that pack the implicated formula. Both companies were cited for food safety deficiencies and both have submitted corrective plans, which are under review.
During the investigation into the 2025 outbreak, Organic West Milk provided FDA with an incomplete customer list. The list did not indicate that they supplied milk to manufacturers of Nara Organics infant formula.
