The New York State Department of Health has issued an updated alert to parents and caregivers following the U.S. Food and Drug Administration’s (FDA) expanded recall of all ByHeart Whole Nutrition Infant Formula products. This action comes after a multistate outbreak of infant botulism linked to certain lots of powdered infant formula.
According to the department, there have been 15 reported cases of infant botulism across 10 states so far. No confirmed cases have been identified in New York State, but officials are monitoring the situation closely and have distributed a Health Advisory Notice to healthcare providers and hospitals throughout the state.
“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,” said State Health Commissioner Dr. James McDonald. “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.”
ByHeart, headquartered in New York City, distributed the recalled formula nationwide. Although contamination of powdered infant formula is uncommon, Clostridium botulinum spores can lead to serious illness in infants under one year old.
Symptoms of infant botulism include constipation, poor feeding, drooping eyelids, weak cry, and muscle weakness. The department advises immediate medical attention if any symptoms appear.
The health department is increasing surveillance for potential cases and working with clinical laboratories and its Wadsworth Center public health laboratory for testing support and case investigations.
On average, between one and four cases of infant botulism are reported annually in New York State outside New York City. Healthcare providers are reminded that while powdered infant formula is generally considered safe, it can sometimes contain C. botulinum spores.
Consumers seeking more information on the recall can visit the FDA recall webpage for updates, product images, and guidance on proper disposal or replacement procedures.
Further details about infant botulism can be found at the CDC’s page on Botulism.
