Nearly 40 infants across the United States have been hospitalized in a rare outbreak of infant botulism linked to contaminated ByHeart powdered formula, prompting a sweeping recall and a renewed focus on the safety of baby food. The U.S. Food and Drug Administration (FDA) reported that 39 confirmed or suspected cases have emerged since August, spanning 18 states and affecting babies as young as two weeks and as old as nine months. The most recent illness was reported on November 19, 2025, according to the FDA’s latest update.
ByHeart, a New York-based manufacturer that accounts for about 1% of the U.S. infant formula market, issued a voluntary recall of all its products sold nationwide on November 11. Despite the recall, some ByHeart products have remained on store shelves at major retailers like Walmart, Target, Kroger, Acme, and Shaw’s, the FDA acknowledged in early December. The agency said it is working closely with state partners and retailers to ensure these products are swiftly removed, emphasizing, “All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online.”
The outbreak, which was officially announced on November 8, has thrust families into turmoil. All 39 infants were hospitalized after consuming ByHeart powdered formula, though, remarkably, no deaths have been reported. The affected states include Arizona, California, Idaho, Illinois, Kentucky, Maine, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.
Botulism is a rare but potentially deadly disease caused by a toxin-producing bacterium that can lead to paralysis and, in severe cases, death. Symptoms in infants may take up to 30 days to develop and include poor feeding, loss of head control, drooping eyelids, a flat facial expression, and general floppiness. Some babies may struggle to swallow or breathe, requiring intensive hospital care. According to the Centers for Disease Control and Prevention (CDC), infant botulism typically affects fewer than 200 babies in the U.S. each year.
California health officials confirmed that an open can of ByHeart formula fed to a sick infant contained the bacteria responsible for producing the botulism toxin. "These mice got sick really quickly," said Dr. Erica Pan, California’s state health officer, describing the tests used to confirm contamination. However, unopened cans have not tested positive for the bacteria, and ByHeart maintains that the microorganism is widespread in the environment and could have come from sources other than their formula.
Some families have reported cases of infant botulism linked to ByHeart formula as early as late 2024 and early 2025—months before the nationwide recall. Amy Mazziotti of Burbank, California, told the Associated Press that her five-month-old son, Hank, was treated for botulism in March, weeks after he began drinking ByHeart formula. "As soon as she heard the ByHeart baby formula was recalled, Mazziotti said she thought: 'This cannot be a coincidence.'"
Despite these early reports, the California Department of Public Health stated, "We cannot connect any pre-August 1 cases to the current outbreak," even though some previously unopened formula samples were found contaminated with the bacteria. Investigators have not identified any other formula brands or sources linked to the outbreak.
ByHeart, for its part, has said, "We are conducting testing, with a third party independent testing laboratory, of the two recalled batches of our formula using food safety testing best practices, to provide you results that we all can feel confident in." The company added, "From the very beginning, we have acted quickly and decisively to remove any potential risk—immediately voluntarily recalling the relevant batches of our formula that the FDA told us were consumed by infants in their investigation." ByHeart officials advise parents and caregivers to stop using the formula immediately and dispose of any cans with the recalled batch codes, offering support and replacement formula at no cost.
The FDA’s inspection teams have visited ByHeart’s production facilities in Allerton, Iowa, and Portland, Oregon, as part of their investigation. The current outbreak is the first known instance of infant botulism tied to powdered formula, according to research studies cited by the Associated Press. Previous formula-related outbreaks, such as the 2021-2022 crisis involving Abbott Nutrition, were caused by different bacteria (cronobacter sakazakii) and led to plant closures and nationwide shortages. In contrast, ByHeart’s market share is small—about 200,000 cans sold monthly—so experts say the risk of a new formula shortage is low.
The only treatment for infant botulism is BabyBIG, an intravenous medication developed by California’s Infant Botulism Treatment and Prevention Program, and the sole source worldwide. Made from the pooled blood plasma of adults immunized against botulism, BabyBIG can shorten hospital stays and reduce the severity of illness. The treatment is costly, with each vial priced at approximately $69,300, but all babies sickened in the ByHeart outbreak have received it, according to the CDC.
This crisis comes on the heels of other safety concerns for ByHeart. In 2022, the company recalled five batches of formula after a sample at its packaging plant tested positive for cronobacter sakazakii. The FDA followed up in 2023 with a warning letter detailing “areas that still require corrective actions.” That same year, a ByHeart plant in Reading, Pennsylvania, was shut down after inspectors found mold, water leaks, and insects, according to inspection documents.
Families of affected infants have filed lawsuits in federal courts, alleging that ByHeart’s formula was defective and that the company was negligent in selling it. The lawsuits seek compensation for medical expenses, emotional distress, and other damages.
The outbreak has also spurred a broader review of infant formula safety in the U.S. Under the direction of Health Secretary Robert F. Kennedy Jr., the FDA has launched “Operation Stork Speed”—an initiative to overhaul testing and regulation of infant formula ingredients. This marks the first comprehensive review of formula nutrients and contaminants since 1998. The agency now plans to increase testing for heavy metals such as arsenic, lead, and mercury, as well as other potential hazards, in an effort to restore parental confidence and prevent future crises.
As the investigation continues, parents and caregivers are urged to check their formula supplies carefully and to heed recall notices. The FDA, CDC, and ByHeart all stress the importance of discarding any recalled formula and seeking medical attention if an infant shows signs of botulism. While the outbreak has rattled families and reignited debate over food safety, officials remain confident that swift action and enhanced oversight will help protect the nation’s youngest and most vulnerable.
