Update: New York State Department of Health Alerts Parents and Caregivers to Expanded FDA Recall of All Byheart Infant Formula Due to Risk of Infant Botulism

FDA Expands Recall to Include All ByHeart Whole Nutrition Infant Formula Products

Poses an Urgent Risk to Infants; Families Advised to Reach Out to Medical Providers with Concerns

No Cases Reported in New York State; Department Issues Updated Health Advisory and Increases Surveillance

ALBANY, N.Y. (November 11, 2025) — The New York State Department of Health is updating its alert to parents and caregivers regarding today's U.S. Food and Drug Administration (FDA) announcement that all ByHeart Whole Nutrition Infant Formula products have been recalled. This follows the original recall for specific lots of its powdered infant formula following a multistate outbreak of infant botulism.

To date, 15 cases of infant botulism have been reported across 10 states. No confirmed cases have been identified in New York State, but the Department of Health is actively monitoring the situation and is issuing a Health Advisory Notice (HAN) to health care providers and hospitals statewide.

"It's critically important that we inform the public of this updated recall as it now includes all infant formula products by this company rather than a selected few," State Health Commissioner Dr. James McDonald said. "We urge parents and caregivers to immediately stop using all ByHeart Whole Nutrition Infant Formula products and follow the FDA's instructions for safe disposal or replacement. While no cases have been reported in New York State, the Department is closely coordinating with FDA, CDC and local health departments to ensure New York families remain safe and informed."

The recalled formula was distributed nationwide by ByHeart, a company headquartered in New York City. While contamination of powdered infant formula is rare, Clostridium botulinum spores can cause a serious illness in infants under one year of age.

Infant botulism symptoms can include constipation, poor feeding, drooping eyelids, weak cry and muscle weakness. Parents and caregivers should seek medical care immediately if an infant shows signs of illness.

The Department is conducting enhanced surveillance for infant botulism and coordinating with clinical laboratories and the Wadsworth Center, New York's public health laboratory, to support testing and case investigation.

Each year, 1–4 cases of infant botulism are reported in New York State (outside of New York City). The Department reminds health care providers that powdered infant formula, while generally safe, can occasionally contain C. botulinum spores.

Consumers can visit the FDA recall webpage for updated information, product photos and instructions for disposal or replacement.

For additional information about infant botulism visit: About Botulism | Botulism | CDC.