From Fox Business: At least 51 babies have been hospitalized in a growing botulism outbreak tied to contaminated baby formula, federal health officials announced Wednesday.
The Food and Drug Administration (FDA) said suspected and confirmed cases have now been reported in 19 states among infants who consumed ByHeart formula — up from 39 cases across 18 states one week ago.
Based on the CDC’s expanded review of the cases, infants as young as 2 weeks and up to 8 months old have been falling ill since Dec. 24, 2023. No deaths have been reported.
Cases have been reported in Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington and Wisconsin.
In a press release, the FDA advised, “Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.”
The FDA also shared the following recommendations:
- Parents and Caregivers should stop using any ByHeart infant formula products immediately.
- If your child consumed ByHeart formula and is experiencing symptoms (see below) seek immediate medical attention.
- If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.
- If you still have the formula in your home, you should:
- Take a photo or record the information on the bottom of the package.
- Keep the container in a safe spot and be sure to label that product as DO NOT USE.
- If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
- Parents and Caregivers with concerns about this outbreak and infant botulism can also contact the California Department of Public Health (CDPH) hotline at 1-833-398-2022 (available Monday to Friday from 7am to 7pm PST).
- Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
- Retailers should ensure recalled product is not on store shelves, including product that has been returned by customers.
- Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate medical attention.
- If you are a Physician and suspect an infant patient has botulism, immediately call the CDPH clinical support line at 510-231-7600 for case consultation. Consultation is available 24/7.
RECALL UPDATE: All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. https://t.co/umKvtkXgtI pic.twitter.com/ABTAUPo8jC
— U.S. FDA (@US_FDA) November 11, 2025
Outbreak Investigation of Infant Botulism – Do not use certain lots of ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing. https://t.co/umKvtkWIEa pic.twitter.com/NwjMCsEkeS
— U.S. FDA (@US_FDA) November 8, 2025
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