11/10/2025
INFANT FORMULA RECALL: The U.S. Food and Drug Administration and CDC are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington. There are no deaths reported at this time.
South Carolina has not been affected at this time and WIC participants in South Carolina do not receive this formula. But parents and caregivers are asked to be aware of the affected lots of ByHeart Whole Nutrition Infant formula and should throw any of these products away immediately.
The reported increase in botulism type A infections have been found among infants consuming ByHeart powdered infant formula produced from August to November 2025.
On Nov. 8, 2025, ByHeart Inc. recalled the following two lots of Whole Nutrition Infant Formula:
- Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
- Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")
If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.
Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.