Updated November 11 with additional cases and recall expansion. A botulism outbreak linked to ByHeart Whole Nutrition Infant Formula includes at least 15 illnesses in 12 states. Additional cases are under investigation.
Foodborne botulism is a severe, sometimes fatal illness caused by a toxin from Clostridium botulinum bacteria, which attacks the nervous system, causing difficulty breathing and muscle paralysis.
Do You Need a Botulism Lawyer?
How Does a Baby Get Botulism and What are the Symptoms?
Infants can get botulism when they ingest formula containing Clostridium botulinum spores. Doctors treat infant botulism with a product called BabyBIG.
Symptoms, which can take as long as several weeks to develop, include:
- Constipation
- Difficulty feeding (sucking and swallowing)
- A weak or altered cry
- Drooping eyelid
- Sluggish pupils
- Weakened neck muscle/ inability to hold up the head
Botulism can be fatal. If you think your baby has botulism, see a doctor immediately.
ByHeart Botulism Outbreak
How many babies are sick? Where do they live?
The infants sickened in this outbreak range in age from 16 days to approximately 6 months old. All 15 of them were fed ByHeart Whole Nutrition infant formula before they became ill. All of them required hospitalization and treatment with BabyBIG. Additional cases are being investigated.
From August 2025 to November 2025, 12 states reported cases: 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).
California Finds the Link
The California Department of Public Health tested one sample of the formula collected from a sick baby’s home and preliminary results indicate it was contaminated with Clostridium botulinum. Further testing is underway.
“We have tested a sample of the specific powdered infant formula linked with these cases, and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately,” said Dr. Erica Pan, CDPH Director and State Public Health Officer.
There Could Be Dozens of Cases
According to the Infant Botulism Treatment and Prevention Program (IBTPP), between August 1 and November 10, 2025, 84 infants have been treated with BabyBIG. Thirty-six of them had some powdered infant formula exposure. Of those, 15 had consumed ByHeart Whole Nutrition Infant Formula. Because the FDA’s data show that ByHeart accounts for about 1 percent of all formula sales, this information shows a disproportionate number of illnesses linked to ByHeart.
ByHeart Received FDA Warning Letter After a Cronobacter Recall in 2022
In 2022, ByHeart issued a recall for formula contaminated with Cronobacter, a bacteria that causes severe, sometimes fatal illness. After the recall, the FDA inspected the company’s Pennsylvania facility and found “significant violations.” When these were not adequately addressed, the FDA issued a warning letter citing ByHeart’s failure to:
- “Establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment“
During a records review, Inspectors discovered that some batches of potentially contaminated formula entered commerce, a violation of the law.
ByHeart Botulism Recall
Initially, ByHeart recalled two lots of Whole Nutrition Formula. But after CA health officials found Clostridium botulinum bacteria in a container of formula collected from a sick baby’s home, the U.S. Food and Drug Administration (FDA) asked the company to recall all of the formula on the market, and ByHeart agreed. Consumers who have ByHeart formula at home should not use it.
What To Do If You Bought This Formula
- Don’t use recalled infant formula. Take pictures of the container, record the lot number, 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.
Related
Infant Botulism Treatment and Prevention Program
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.
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