The ByHeart botulism outbreak strain has been found in a sample of organic whole milk powder used to make the infant formula, according to the FDA. The outbreak strain was also found in a closed product sample of the formula obtained by the FDA. The outbreak strain is Type A.
The case count has not changed since December 15, 2025. The case count by state is: Arizona (5), California (12), Idaho (2), Illinois (2), Kentucky (1), Massachusetts (2), Maine (1), Michigan (1) Minnesota (3), North Carolina (2), New Jersey (1), Ohio (1), Oregon (4), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1). The infants range in age from 16 to 264 days. Illness onset dates range from December 24, 2023 to December 1, 2025. All of the infants were treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
The FDA collected the organic whole milk powder sample at a processor for a supplier to ByHeart. The sample was analyzed by the New York Wadsworth Laboratory. The supplier and processor were not named.
The update states that the FDA’s investigation to find the source of the contamination is ongoing, even though these results help the agency understand the outbreak.
The FDA also states that the detection of Clostridium botulinum in infant formula, or the ingredients used to make it, are complex, and confirmation of results can take weeks. Part of the issue is that the heat-resistant spores that the pathogen creates must be activated in a specific process before they can be detected. In addition, testing for this pathogen and its spores in infant formula requires specialized testing and lab equipment. There are not many laboratories that have this type of equipment and the resources to conduct these tests.
This is the first documented outbreak of infant botulism ins the U.S. linked to a contaminated infant formula. All ByHeart infant formula products have been recalled, and they should not be available for sale anywhere.
If you still have any ByHeart infant formula product in your home, do not feed it to your child. You can throw it away or return it to the place of purchase for a refund. And it’s a good idea to familiarize yourself with the symptoms of infant botulism, which differ from adult botulism symptoms.
If your child has been sickened with an infant botulism food poisoning infection, please contact our experienced attorneys for help with a possible lawsuit at 1-888-377-8900 or text us at 612-261-0856. Our firm represents clients in lawsuits against grocery stores, restaurants, and food processors.
