The California Department of Public Health (CDPH) has announced a multistate investigation into an infant botulism outbreak connected to specific lots of ByHeart Whole Nutrition Infant Formula. California’s Infant Botulism Treatment and Prevention Program was the first to detect an unusual increase in cases and notified the U.S. Centers for Disease Control and Prevention, prompting a nationwide response.
ByHeart has issued a voluntary recall of two lots of its powdered formula that carry a “Use by 01 Dec 2026” date. Families who have this product are urged to stop using it immediately and keep the container so local health departments can provide guidance.
Infant botulism is very rare, but early identification is critical. Signs can include constipation, difficulty feeding, weak cry, poor head control, and general muscle weakness. Parents who notice any of these symptoms should contact their healthcare provider right away.
CDPH is working closely with CDC, FDA, and state partners to test formula samples, identify additional cases, and support providers with access to BabyBIG, the only FDA-approved treatment for infant botulism. California remains the sole producer of BabyBIG and continues to lead global response efforts for infant botulism care.
To read the full CDPH news release and see the most current updates, visit:
https://www.cdph.ca.gov/Programs/OPA/Pages/CAHAN/Outbreak-of-Infant-Botulism-Linked-to-ByHeart-Infant-Formula.aspx