Charleston, W. Va. – The West Virginia Department of Health (DH), Bureau for Public Health, Office of Epidemiology and Prevention Services, is alerting parents and caregivers that ByHeart has voluntarily recalled certain lots of its powdered infant formula following a multistate outbreak of infant botulism.
The recall was announced by the U.S. Food and Drug Administration (FDA) on Saturday, November 8, 2025.
To date, 13 cases have been reported across 10 states. No confirmed cases have been identified in West Virginia; however, DH is enhancing surveillance activities statewide.
“Protecting the health of West Virginia infants and families is our highest priority,” said Dr. Mark McDaniel, Acting State Health Officer. “Parents and caregivers should immediately stop using any recalled ByHeart powdered formula and follow FDA guidance for checking lot numbers, safely disposing of the product, and requesting a replacement.”
Infant botulism is a rare but serious illness caused by Clostridium botulinum spores. Symptoms can include constipation, poor feeding, weak cry, drooping eyelids, and muscle weakness. Parents should seek medical care immediately if an infant shows any signs of illness.
Consumers can find information on affected lots and disposal instructions on the FDA recall webpage.
For more information about infant botulism, visit the CDC Botulism webpage.
The West Virginia Department of Health (DH) seeks to advance the health and well-being of all West Virginians promoting healthy behaviors, working to mitigate public health crises, and increasing access to health-related resources and information.
