11/13/2025
ATTENTION: All ByHeart Whole Nutrition Infant Formula products have been recalled.
FDA is expanding its recommendation to include all ByHeart infant formula products due to the number of ill infants with suspected infant botulism reported to have consumed this product.
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.
Parents and Caregivers should stop using any ByHeart infant formula products immediately.
If your child consumed ByHeart formula and is experiencing symptoms 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.
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.
