The CDC and FDA have announced a multistate outbreak of infant botulism. As of November 10th, there have been 15 suspected or confirmed cases with confirmed exposure to Byheart Whole Nutrition Infant Formula from 12 different states. On November 11th, ByHeart recalled all ByHeart formula nationwide. The FDA is currently investigating to determine the point of contamination. We will continue to provide updates as they are released.
What you can do:
Do not use any ByHeart Whole Nutrition infant formula. If you have leftover ByHeart powdered formula, label it "DO NOT USE" and keep it stored in a safe place for at least a month. If possible, take a picture or record the lot number and best by date. If your infant starts to develop symptoms, the state health department may want to collect the formula for testing. If no symptoms appear after a month, throw the leftover formula away. At this time, if your infant has consumed ByHeart Formula, monitor them for symptoms including:
- Poor feeding
- Loss of head control
- Difficulty swallowing
- Decreased facial expressions.
Additionally, wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
Symptoms can take several weeks to develop so it is important to remain vigilant. If your infant has consumed ByHeart formula and experiences any of these symptoms, it is vital to seek immediate medical care. For more information, please visit Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA or the Infant Botulism Outbreak Linked to Infant Formula, November 2025 | Botulism | CDC.