11/13/2025
Infant Botulism Outbreak Linked to Infant Formula, November 2025
All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks.
CDC and FDA are concerned that other lots of ByHeart Whole Nutrition infant formula may be contaminated and are making infants sick with infant botulism. Parents and caregivers have reported feeding infants in this outbreak different lots of ByHeart infant formula that were not included in the company's recall on November 8, 2025. On November 11, 2025, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products.
Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately.
This includes:
All lot numbers
All sizes of cans and single serve packets
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
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.