NEW YORK, Nov. 10, 2025: Federal health officials have confirmed 13 cases of infant botulism across 10 U.S. states linked to ByHeart’s Whole Nutrition Infant Formula, prompting a nationwide recall of two production lots and an ongoing investigation into possible contamination at the company’s facility. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said all affected infants were hospitalized, though no deaths have been reported. The illnesses were identified in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. Each of the infants had reportedly consumed formula from the same brand before developing symptoms consistent with infant botulism.
ByHeart, a New York-based infant formula manufacturer, voluntarily recalled two lots of its Whole Nutrition Infant Formula Lot 206VABP/251261P2 and Lot 206VABP/251131P2 both bearing the “Use by 01 Dec 2026” label. The company said it is fully cooperating with the FDA and has temporarily paused production pending additional testing and a safety review. The recall was initiated after the California Department of Public Health confirmed the presence of Clostridium botulinum in a formula sample consumed by one of the affected infants. The bacteria can produce a toxin that causes paralysis and, in severe cases, respiratory failure if not treated promptly.
The CDC described the outbreak as “rare but serious,” noting that early medical intervention is essential for recovery. Infant botulism occurs when spores of the bacteria germinate and produce toxins inside an infant’s gastrointestinal tract, typically affecting babies under one year of age. Symptoms often begin with constipation, followed by poor feeding, weak cry, loss of head control, and general muscle weakness that can lead to breathing difficulties. All 13 infants remain under medical care, and their conditions are being closely monitored by local health departments and pediatric specialists.
FDA confirms ByHeart recall details amid US outbreak
The FDA said the affected ByHeart lots represent less than one percent of the national infant formula supply and are not expected to impact availability across the country. The agency urged parents and caregivers to check their formula containers immediately and to dispose of or return any cans belonging to the recalled lots. Officials also advised thorough cleaning and sanitization of all bottles, scoops, and surfaces that may have come into contact with the product. ByHeart said in a statement that no other product batches have shown signs of contamination. The company emphasized that the recall was voluntary and issued “out of an abundance of caution” as the investigation continues.
Outbreak underscores formula industry safety vigilance
The firm also noted that it had implemented additional quality assurance steps, including environmental monitoring and third-party microbial testing. This is the first known outbreak of infant botulism associated with commercial baby formula in the United States. Previous cases of infant botulism were typically linked to environmental exposure or natural food sources such as honey. Health officials said identifying formula as a possible source underscores the importance of strict manufacturing oversight in the infant nutrition industry. The FDA and CDC are conducting joint inspections and tracing supply chain routes to determine the source and scope of contamination.
Local and state health departments are collaborating with federal agencies to identify any additional cases and ensure rapid reporting of potential symptoms. Parents and caregivers who suspect their infant may have been exposed are advised to seek medical care immediately. Early administration of botulism antitoxin can prevent progression of paralysis and significantly improve recovery outcomes. Consumers can verify product lot numbers and obtain detailed recall information on the FDA and CDC websites. The agencies said updates will continue to be released as new data becomes available. – By Content Syndication Services.