A nationwide recall has been issued for ByHeart Inc.‘s Whole Nutrition Infant Formula following a series of serious health concerns linked to infant botulism. The North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture and Consumer Services have confirmed that 13 cases of this life-threatening illness have been reported across ten states, with one additional case currently under investigation in North Carolina.
The U.S. Food and Drug Administration (FDA) has identified two specific lots of the formula that are subject to recall. Parents and guardians are advised to pay close attention to the following lot numbers: 206VABP/251261P2 and 206VABP/251131P2. Both lots have a Use by date of December 1, 2026.
In an official statement, Steve Troxler, North Carolina’s Agriculture Commissioner, emphasized the importance of the situation, stating that the Food and Drug Protection Division is actively monitoring the issue and has begun removing the recalled products from store shelves. However, the risk remains significant due to potential online sales, making vigilance at home essential.
Botulism is a severe paralytic illness caused by the bacteria Clostridium botulinum, and can be fatal. Each confirmed case is treated as a medical emergency. In light of the outbreak, NCDHHS has reached out to healthcare providers, urging them to be alert for symptoms indicative of infant botulism.
Dr. Kelly Kimple, Director of the NCDHHS Division of Public Health, highlighted the seriousness of the situation: “Infant botulism is a serious illness and can be life-threatening. NCDHHS is working with our public health and healthcare partners to ensure parents do not use the recalled formula to prevent further exposure among infants in North Carolina.”
For families who possess the affected formula, the health department strongly advises against its use. Instead, parents should dispose of the product or return it for a refund at the point of purchase. Items or areas that may have come into contact with the formula should be thoroughly cleaned with hot, soapy water or sanitized in a dishwasher. Keeping a record of the lot number or taking a photograph of the label is recommended before disposal or return.
Parents should remain vigilant for symptoms of botulism, which can take weeks to appear. Warning signs include poor feeding, difficulty swallowing, reduced facial expressions, loss of head control, and respiratory issues. If any of these symptoms are observed, immediate medical attention is crucial.
Despite the recall, there is no immediate cause for concern regarding a shortage of infant formula. ByHeart Inc.’s Whole Nutrition Infant Formula comprises approximately 1% of total U.S. sales. Additionally, this product is not part of the Supplemental Nutrition Assistance Program (SNAP) or Women, Infants, and Children (WIC) program, ensuring that alternative infant formulas remain accessible for parents seeking options.
As the situation develops, health officials urge parents to stay informed and exercise caution in their choices regarding infant nutrition.
