Federal health officials are investigating an outbreak of infant botulism linked to recalled ByHeart Whole Nutrition Infant Formula, with 13 cases reported across 10 U.S. states and no fatalities. The recall was initiated on Saturday, November 8, 2025, as authorities work to determine the source of contamination and prevent further illnesses.
On Saturday, November 8, 2025, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announced that they are probing 13 cases of infant botulism connected to baby formula that is being recalled. The outbreak has affected infants in ten states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. All affected infants were hospitalized, but no deaths have been reported, and health officials are coordinating with state agencies to monitor the situation.
ByHeart Inc., a New York-based company, agreed to recall two lots of its Whole Nutrition Infant Formula following the investigation. The recalled lots are 206VABP/251261P2 and 206VABP/251131P2, both with a December 1, 2025, “use by” date. The FDA is working with retailers to remove the product from store shelves and is investigating how the contamination occurred, including whether other products are affected. The formula accounts for less than 1% of national sales and is available online and in major stores.
Infant botulism is a rare but serious illness caused by the bacterium Clostridium botulinum, which produces toxins in the large intestine. Symptoms can take weeks to develop and include constipation, poor feeding, loss of head control, difficulty swallowing, and decreased facial expression. In severe cases, it can lead to paralysis and respiratory failure, but prompt medical treatment can be effective, and no fatalities have occurred in this outbreak.
The CDC and FDA are testing leftover formula samples to confirm the link to the outbreak, with results expected in the coming weeks. ByHeart stated that it was informed by the FDA on Friday about an estimated 83 reports of infant botulism nationwide since August, with 13 cases linked to its product. The company emphasized that no botulism has been detected in its own tests or government tests so far, but it is recalling the formula proactively to ensure safety.
Parents and caregivers who have purchased the recalled formula are advised to record the lot number before discarding it or returning it to the store. They should clean any items or surfaces that came into contact with the formula using hot, soapy water or a dishwasher. Medical care should be sought immediately if an infant shows symptoms after consuming the product, as early intervention is crucial for recovery.
This outbreak highlights ongoing concerns about food safety in infant nutrition, particularly following previous formula recalls. The FDA is assessing the point of contamination and working to prevent further cases, while health officials urge vigilance due to the delayed onset of symptoms. Treatment with BabyBIG, an FDA-approved antibody infusion, is available and can be lifesaving if administered promptly.
Authorities continue to investigate the outbreak, and updates are expected as more information becomes available. Consumers are encouraged to follow FDA and CDC guidance to protect infant health and prevent the spread of illness.
