Potential Case Under Investigation in North Carolina; Product Sold Nationwide
RALEIGH, N.C. — State health officials are alerting parents, caregivers, and healthcare providers about a nationwide recall of ByHeart Inc. Whole Nutrition Infant Formula following an outbreak of infant botulism.
According to the U.S. Food and Drug Administration (FDA), as of Nov. 8, there have been 13 confirmed cases of infant botulism across 10 states. The North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture and Consumer Services (NCDA&CS) report that one possible case is currently under investigation in North Carolina.
The recall includes the following two lots of ByHeart formula, which were sold nationwide:
- Lot: 206VABP/251261P2 — Use by 01 Dec 2026
- Lot: 206VABP/251131P2 — Use by 01 Dec 2026
Health officials are urging consumers to check their formula containers immediately and stop using any product from the affected lots. Parents who believe their child may have consumed the recalled formula should contact their pediatrician right away.
The FDA and state health departments continue to investigate the source of contamination.
