Since August, the Centers for Disease Control and Prevention (CDC) has reported 13 cases of infant botulism in infants who consumed ByHeart brand powdered infant formula. The cases have been identified in 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The affected infants range in age from 16 days to several months old. No deaths have been reported. Of the reported cases, six have been confirmed through laboratory testing that detected botulinum toxin type A. Testing is pending for the remaining cases. No cases have been reported in Montana to date.
ByHeart is a small manufacturer with national distribution, including retail stores in Montana and online merchants. Despite its small market share, the number of reported cases linked to this product is highly unusual and a public health concern.
FDA Recall Information
The U.S. Food and Drug Administration (FDA) has announced a recall of two lots of ByHeart powdered infant formula. This recall is not expected to cause a national formula shortage.
Recalled lots include:
- Lot: 206VABP/251261P2 — Use by 01 Dec 2026
- Lot: 206VABP/251131P2 — Use by 01 Dec 2026
Consumers are encouraged to visit the FDA’s website for recall updates as the investigation continues: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA
About Infant Botulism
Infant botulism is the most common form of botulism in the U.S., affecting infants under 12 months. Symptoms can include constipation, poor feeding, weak cry, loss of head control, and muscle weakness. Signs may appear up to 30 days after exposure.
Recommendations for Parents and Caregivers
Stop using the recalled formula and record information from the bottom of the container before discarding. Seek immediate medical care at the nearest emergency room if your child shows any symptoms.
For more information, visit the FDA and CDC websites or contact CCHD.
Author: Staff
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