Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)

Product:

All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve "anywhere" sticks.

FDA is expanding its recommendation to include all ByHeart infant formula products due to the number of ill infants reported to have consumed this product, the identification of additional lot codes, the identification of new cases of suspected infant botulism, and the preliminary positive sample collected and tested by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP).

ByHeart infant formula products makes up less than 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.

Symptoms of Infant botulism

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.

Stores affected

ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.

Status

Ongoing

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.