New York State Health Department warns parents after FDA expands recall of all ByHeart infant formula over potential botulism risk

Albany, New York – The New York State Department of Health has issued a new warning to parents and caregivers following an expanded U.S. Food and Drug Administration (FDA) recall of all ByHeart Whole Nutrition Infant Formula products. The move comes after federal officials linked the products to a multistate outbreak of infant botulism, a rare but serious illness affecting babies under one year old.

According to the FDA, 15 cases of infant botulism have been reported in 10 states. While no confirmed cases have been identified in New York, state health officials say they are closely monitoring the situation and have issued a Health Advisory Notice (HAN) to hospitals and health care providers statewide.

State Health Commissioner Dr. James McDonald emphasized the urgency of the expanded recall, noting that it now applies to all products made by ByHeart, not just the limited batches originally affected. “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,” 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, which was distributed nationwide, is produced by ByHeart, a company based in New York City. Health officials stress that contamination of powdered infant formula is uncommon, but the presence of Clostridium botulinum spores poses a serious health threat to infants. When ingested, these spores can produce toxins that attack the body’s nervous system, leading to muscle weakness and breathing difficulties.

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Symptoms of infant botulism can appear gradually and may include constipation, poor feeding, drooping eyelids, a weak cry, and muscle weakness. In severe cases, the illness can cause paralysis or respiratory failure. Health experts urge parents and caregivers to seek immediate medical attention if their child shows any signs of these symptoms.

The state’s health department has launched enhanced surveillance measures to detect potential cases of infant botulism. This includes coordination with clinical laboratories and the Wadsworth Center, New York’s public health laboratory, which is assisting in testing and case investigations.

Although infant botulism is rare, New York typically records between one and four cases each year, excluding those in New York City. Officials say these numbers serve as a reminder that even though powdered infant formula is generally safe, it can occasionally contain harmful bacteria.

The Department of Health is encouraging all consumers to check their formula containers immediately and stop using any products labeled as ByHeart Whole Nutrition Infant Formula. Families are advised to follow the FDA’s recall instructions, which outline how to dispose of or replace affected formula safely.

Consumers can visit the FDA recall webpage for detailed information, including product photos, lot numbers, and refund instructions. Parents with questions or concerns can also contact their pediatrician for guidance on safe alternative feeding options.

While the recall may cause concern among new parents, public health officials emphasize that the swift response from both state and federal agencies aims to protect infants from further risk. The Department of Health continues to work with the Centers for Disease Control and Prevention (CDC) and the FDA to track potential cases and ensure that no contaminated products remain in circulation.

Botulism itself is caused by a toxin produced by the bacterium Clostridium botulinum, which can thrive in low-oxygen environments such as improperly processed food. In infants, the bacteria can grow in the intestines and release toxins that block nerve function, leading to weakness and paralysis. Early detection and medical treatment are essential to prevent complications and promote recovery.

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Officials remind caregivers that prevention is key. Using properly prepared formula, keeping feeding equipment clean, and following storage instructions can help reduce the risk of contamination. Parents who rely on infant formula are encouraged to stay informed about product recalls and report any suspected adverse effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

For up-to-date details on the recall, including guidance for safe feeding practices, consumers can visit www.fda.gov/safety/recalls-market-withdrawals-safety-alerts. Additional information about infant botulism is available on the CDC website under “About Botulism | Botulism | CDC.”

As Dr. McDonald noted, awareness and vigilance remain crucial: “We want New York families to feel confident that we are doing everything possible to ensure their safety. The best step parents can take right now is to stop using the recalled formula and consult their health care provider for alternatives.”

With swift action and ongoing monitoring, health officials hope to prevent further cases and reassure parents that their babies’ safety is the state’s top priority.