A significant outbreak of infant botulism has been linked to ByHeart infant formula, resulting in hospitalization for 51 infants across 19 states. The U.S. Food and Drug Administration (FDA) confirmed the alarming rise in cases on December 10, 2025, marking an increase from 39 cases previously reported earlier this month. Botulism, though rare, poses serious health risks, including paralysis and death, particularly in vulnerable infants.
The reported illnesses stem from infants who consumed the affected ByHeart formula, with symptoms manifesting between August 9 and November 19, 2025. Affected states include Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin, with Ohio being the latest addition to the list of impacted areas.
According to the FDA, all infants involved in this outbreak were hospitalized, although no fatalities have been reported to date. The outbreak’s confirmation includes cases dating back to August 1, 2025, with the Centers for Disease Control and Prevention (CDC) and state health authorities identifying an additional ten cases that occurred from December 2023 through July 2025.
The FDA has emphasized that all ByHeart infant formula products have been recalled and should not be available for sale in stores or online. This recall encompasses all formula cans and single-serve “anywhere pack” sticks. Despite the recall, some consumers reported finding ByHeart products still on store shelves, including major retailers such as Walmart, Target, and Kroger.
In light of these developments, parents and caregivers are urged to stop using the formula and dispose of any remaining cans. ByHeart has been proactive in addressing the situation, stating on November 9 that they are conducting comprehensive testing in collaboration with a third-party independent laboratory. The company’s statement highlighted their commitment to swift action in recalling the relevant batches of formula.
Testing has confirmed that a sample from an open can of ByHeart formula fed to a sick infant contained the bacteria responsible for the botulism toxin. Dr. Erica Pan, California’s state health officer, noted that tests conducted on mice showed rapid illness, underscoring the potency of the bacteria involved.
Botulism is primarily caused by a type of bacteria that produces a toxin in the intestines, with infants particularly susceptible due to their underdeveloped gut microbiomes. Symptoms can take weeks to appear and may include poor feeding, loss of head control, drooping eyelids, and a generally floppy appearance. The only known treatment is BabyBIG, an intravenous medication derived from the pooled blood plasma of adults immunized against botulism.
While the current outbreak has raised concerns, experts suggest there is minimal risk of widespread formula shortages as ByHeart holds only about 1% of the U.S. infant formula market. This situation contrasts sharply with the significant outages experienced in 2021 and 2022, when Abbott Nutrition faced recalls following the deaths of two infants linked to contaminated products.
As investigations continue, health officials remain vigilant. The FDA and CDC are working closely with ByHeart and state partners to ensure thorough testing and monitoring. The results of ongoing testing are anticipated in the coming weeks, with health authorities committed to safeguarding the well-being of infants nationwide.
