The ByHeart infant botulism outbreak has now sickened 51 babies in 19 states, according to the CDC. All of the patients have been hospitalized. That is an increase of 12 new cases, 12 new hospitalizations, and one new state since the last update was issued a week ago. The new state is Ohio.
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 hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
Epidemiologic and laboratory data show that ByHeart Whole Nutrition Infant Formula is contaminated with Clostridium botulinum and has made infants sick.
This new update states that the FDA can’t rule out the possibility that contamination may have occurred in all of ByHeart’s products. The CDC has broadened the case definition for the investigation to include any infant with botulism who was exposed to ByHeart formula at any time since the products were released in March 2022.
With this new definition, 10 additional cases that occurred between December 2023 to July 2025 have been identified. All 10 are confirmed infant botulism cases with documented exposure to ByHeart infant formula.
If you have any ByHeart formula, do not feed it to your child. You can throw it away in a secure trash can, or you can take it back to the store where you purchased it for a full refund.
If you fed your child any ByHeart formula, monitor their health for the symptoms of infant botulism for the next few weeks. If they do get sick, take them to an emergency room or their pediatrician as soon as possible and tell the doctor they were fed ByHeart formula.
If your baby has been sickened with and 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.
