Infant formula recall, potential botulism contamination prompts local alert

The Hawaiʻi Department of Health Food and Drug Branch and the U.S. FDA announced on November 12, 2025 that ByHeart Inc. had recalled Whole Nutrition Infant Formula because of possible contamination with Clostridium botulinum, the bacterium that can cause infant botulism. The recall began with two batches and was later expanded to include all batches while the company and federal investigators completed further testing. A Kauaʻi Now update on the same day listed the sizes and batch codes included in the initial recall and noted that additional batches were under review.

Local retailers that serve Kauaʻi moved quickly to cooperate with public health officials and remove recalled product from store shelves. Parents and caregivers were advised to stop using any ByHeart formula until the company and regulators completed their checks. The product had been sold online and through national retailers that deliver to Hawaiʻi, increasing the number of families who may be affected.

Health authorities emphasized vigilance because infant botulism primarily affects young infants and can progress rapidly. Symptoms to watch for include constipation, poor feeding, a weak or absent cry, generalized weakness or floppy muscle tone, decreased facial expression, and breathing difficulties. Families who have used the recalled formula and notice any of these signs were urged to contact their pediatrician or seek emergency care promptly. Public health guidance also recommended washing feeding utensils and bottles thoroughly, monitoring infants for symptoms, and following disposal instructions for recalled product.

The recall carries immediate practical consequences for families who rely on specific formulas. Caregivers who used ByHeart formula were encouraged to check the Kauaʻi Now update and the notices issued by the Hawaiʻi Department of Health and the U.S. FDA for details on affected batch codes and product sizes, and to follow the provided contact channels from ByHeart and local authorities for next steps. Local health agencies and retailers are coordinating on returns and removals and communicating options to affected customers.

Beyond the acute safety concern, the recall posed challenges for supply and sourcing of infant nutrition on the islands, where shipping and availability can already complicate access. Families in need of alternatives were advised to consult their health care provider, pediatrician, or WIC office for safe replacement options and guidance. State and federal agencies continue to work with the manufacturer on testing and clearance, and Kauaʻi families should monitor official updates for new information and instructions.