New York State Department of Health warns about ByHeart infant formula recall due to botulism risk

James V. McDonald M.D., M.P.H. Health Commissioner at New York State Department of Health
James V. McDonald M.D., M.P.H. Health Commissioner at New York State Department of Health - New York State Department of Health
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The New York State Department of Health has issued a warning to parents and caregivers regarding a voluntary recall of ByHeart powdered infant formula. The recall follows a multistate outbreak of infant botulism, as announced by the U.S. Food and Drug Administration (FDA).

So far, 13 cases of infant botulism have been reported in 10 states. There are no confirmed cases in New York State at this time. The Department is actively monitoring the situation and has released a Health Advisory Notice to health care providers and hospitals throughout the state.

“Protecting infants and young children from preventable illness is our highest priority,” said State Health Commissioner Dr. James McDonald. “We urge parents and caregivers to immediately stop using any recalled formula 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, based in New York City, distributed the recalled formula nationwide. Although contamination in powdered infant formula is uncommon, Clostridium botulinum spores can cause serious illness in infants under one year old.

Symptoms of infant botulism include constipation, poor feeding, drooping eyelids, weak cry, and muscle weakness. Parents are advised to seek medical attention if their child shows these signs.

The Department is increasing surveillance for infant botulism cases and working with clinical laboratories as well as the Wadsworth Center—New York’s public health laboratory—to support testing efforts.

Annually, between one and four cases of infant botulism are reported in New York State outside of New York City. Health care providers are reminded that while powdered infant formula is generally considered safe, it can sometimes contain C. botulinum spores.

For details on affected lots or instructions for product disposal or replacement, consumers can refer to the FDA recall webpage (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts). Additional information about infant botulism can be found on the CDC website (https://www.cdc.gov/botulism/index.html).



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