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. The recall now covers all products from the company, after an initial recall targeted specific lots due to a multistate outbreak of infant botulism.
Fifteen cases of infant botulism have been reported in 10 states, but none have been confirmed in New York State so far. The Department is monitoring the situation closely and has released a Health Advisory Notice to health care 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 its recalled formula nationwide. Contamination of powdered infant formula is rare, but 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 parents and caregivers to seek immediate medical attention if these symptoms appear.
Enhanced surveillance for infant botulism is underway in collaboration with clinical laboratories and the Wadsworth Center, New York’s public health laboratory. Typically, between one and four cases are reported each year in New York State outside of New York City.
Health care providers are reminded that while powdered infant formula is generally considered safe, there remains a risk for contamination with C. botulinum spores.
Consumers seeking more information can visit the FDA recall webpage for updates on affected products as well as instructions for disposal or replacement at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-issues-voluntary-recall-all-byheart-whole-nutrition-infant-formula-due-possible-health-risk.
Further details about infant botulism can be found on the CDC’s website at https://www.cdc.gov/botulism/infant-botulism.html.
