11/12/2025
Outbreak investigation of infant botulism tied to ByHeart Whole Nutrition Infant Formula results in mass recall.
All ByHeart Whole Nutrition Infant Formula products have now 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, and the identification of new cases of suspected infant botulism.
Recommendations for caregivers:
🚨 Stop using all ByHeart infant formula products immediately.
🚨 Seek immediate medical attention if your child is exhibiting symptoms of infant botulism. Symptoms can take several weeks to develop following formula ingestion. They include: constipation, poor feeding, loss of head control, difficulty swallowing, difficulty breathing and respiratory arrest.
🚨 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 at home, mark it as Do Not Use, take a photo of the bottom of the package for lot information, and store for 30 days before disposing. If your child develops symptoms within 30 days of consumption, our state health department may want to collect it for testing.
Refer to FDA recall or manufacturer recall notices for further information. Note that although ByHeart infant formula is sold by major retailers, it comprises less than 1% of all infant formula sold in the US and this recall would not trigger formula shortages.
