The ByHeart infant formula botulism outbreak includes at least one baby in Minnesota. At least 15 babies in 12 states are part of a botulism outbreak, linked to ByHeart Whole Nutrition Infant Formula. Additional cases are under investigation. All ByHeart products have been recalled. Foodborne botulism causes severe illness that can be fatal. People get it when they ingest a toxin from Clostridium botulinum bacteria, which attacks the nervous system, causing difficulty breathing and muscle paralysis.
What are the Symptoms?
Symptoms of foodborne botulism can take as long as several weeks to develop. If you fed your baby ByHeart formula before the recall, watch for these symptoms and seek immediate medical care if they appear.
- Constipation
- Difficulty feeding (sucking and swallowing)
- A weak or altered cry
- Drooping eyelid
- Sluggish pupils
- Weakened neck muscle/ inability to hold up the head
ByHeart Formula Botulism Outbreak
Between August 1 and November 10, 2025, 84 infants received the botulism treatment BabyBIG, according to the Infant Botulism Treatment and Prevention Program (IBTPP). Thirty-six of them were fed powdered infant formula. Of those, 15 had consumed ByHeart Whole Nutrition Infant Formula. ByHeart accounts for about 1 percent of all formula sales, so the number of illnesses associated with that brand of infant formula is disproportionate to market share. The California Department of Public Health tested one sample of the formula collected from a sick baby’s home. Preliminary results indicated it was contaminated with Clostridium botulinum. Further testing is underway.
Between August 2025 to November 2025, 12 states reported 15 cases among infants who consumed ByHeart formula: Arizona (1), California (2), Illinois (2), Kentucky (1), Minnesota (1), New Jersey (1), North Carolina (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). The outbreak patients range in age from 16 days to approximately 6 months old. All 15 were fed ByHeart Whole Nutrition infant formula before they became ill. And all of them required hospitalization and treatment with BabyBIG.
What To Do If You Bought This Formula
- Don’t use ByHeart formula. Take pictures of the container, record the lot number, and save your receipt
- Wash all items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
- Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of the symptoms listed above.
Experienced Botulism Lawyers
The Pritzker Hageman food safety team has a successful track record with botulism cases. To speak with a botulism lawyer about a lawsuit to cover medical bills, disability, and emotional distress, please contact us today by calling 888-377-8900 (toll-free), texting 612-261-0856, or by completing the form below. The call is free, the consultation is free, and there is no obligation.
Our legal team pursues all responsible companies in the distribution chain. We make house and hospital calls nationwide.