November 11, 2025 – ByHeart infant formula manufacturer of organic baby formula, has recalled all of its products sold nationwide due to an outbreak of botulism. At least 15 babies in 12 states have been sickened in the outbreak since August, with more cases pending. All of the infants were hospitalized after consuming ByHeart formula. No deaths have been reported. Click here to learn more about this recall from the Food and Drug Administration.
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.
- Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant 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 510-231-7600 for case consultation. Consultation is available 24/7.