ByHeart, a New York-based manufacturer of organic infant formula, is at the center of a growing health crisis as at least 31 babies across 15 states have been hospitalized with infantile botulism since August 2025, according to the U.S. Centers for Disease Control and Prevention (CDC). The outbreak, which continues to expand, has prompted a nationwide recall of all ByHeart products and triggered urgent warnings from federal and state officials, yet investigators are still finding the recalled formula on store shelves and in homes as recently as mid-November.
Infant botulism, a rare but potentially deadly disease, is caused by bacteria that form spores in a baby’s gut, producing a toxin that can lead to paralysis and, in severe cases, death. The babies affected in this outbreak range in age from just two weeks old to around six months, with the most recent case reported on November 13, 2025. Fortunately, no deaths have been reported so far. The CDC, in a statement, emphasized, “Do not use any ByHeart Whole Nutrition infant formula.”
Despite the recall, state officials in Oregon, Minnesota, and Arizona confirmed to the Associated Press that ByHeart formula was still being sold in some stores a week after the company’s nationwide recall. In Oregon, nine out of more than 150 stores checked still had the product on shelves during the week of November 17. Minnesota investigators found recalled formula at four sites out of 119 checked between November 13 and 17. An Arizona health official also reported finding the product for sale. Minnesota officials urged, “No affected product should be sold or consumed.”
The U.S. Food and Drug Administration (FDA) has launched inspections at ByHeart manufacturing plants in Allerton, Iowa, and Portland, Oregon, but the results of these inspections have not yet been released. ByHeart officials stated they recalled their products “in close cooperation” with the FDA, even though “no unopened ByHeart product has tested positive” for the spores or toxin that cause infant botulism. California health authorities, however, confirmed that the bacteria responsible for the illness was found in an open can of ByHeart formula fed to a sickened infant.
ByHeart, which accounted for about 1% of the U.S. infant formula market and produced roughly 200,000 cans per month, distributed its formula both online and through major retailers like Target and Walmart. A Walmart spokesperson said the company immediately restricted sales, removed the formula from stores, and notified consumers who had purchased it. The formula, which sold for about $42 per can, can be returned to any store for a refund.
Federal and state health officials are urging parents and caregivers to stop using ByHeart formula, including both cans and single-serve sticks. They advise marking any remaining product as “DO NOT USE” and keeping it for at least a month in case a baby develops symptoms—if that occurs, the formula may need to be tested. To support worried families, the California health department has set up a public hotline at 833-398-2022, staffed daily from 7 a.m. to 11 p.m. Pacific Time, which has already fielded hundreds of calls from anxious parents and caregivers.
Symptoms of infant botulism can take up to 30 days to develop and may include constipation, poor feeding, a weak cry, drooping eyelids, a flat facial expression, and “floppy” limbs. Babies may also have trouble swallowing or breathing. All the infants affected in this outbreak were hospitalized after consuming ByHeart powdered formula, and each received treatment with BabyBIG, an intravenous medication developed by California’s Infant Botulism Treatment and Prevention Program. BabyBIG, made from the pooled plasma of immunized adults, is the only treatment available worldwide and costs $69,300 per vial. It works to shorten hospital stays and reduce the severity of illness, but infants often require ventilators due to breathing difficulties.
According to the CDC, infant botulism typically affects fewer than 200 babies in the U.S. each year. As of September 20, 2025, there had been 133 cases reported, with 145 in the previous year. The bacterium responsible is widespread in the environment, with hardy spores that can be found in dust, dirt, water, and even honey. Infants are particularly susceptible because their gut microbiomes are not yet developed enough to prevent the spores from germinating and producing the dangerous toxin.
The outbreak has led to legal action as well. Families of babies treated for botulism after drinking ByHeart formula have filed lawsuits against the company in federal courts, alleging that the formula was defective and that ByHeart was negligent in its sale. The lawsuits seek compensation for medical bills, emotional distress, and other damages. The FDA noted, “ByHeart brand formula is disproportionately represented among sick infants in this outbreak.” Cases have been reported in Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
While this outbreak is alarming, health officials say there is little risk of a nationwide formula shortage. ByHeart’s market share is small, a stark contrast to the crisis in 2021 and 2022 when Abbott Nutrition’s recall and plant shutdown led to months of shortages. However, ByHeart has faced previous regulatory scrutiny: in 2022, the company recalled five batches of formula after a sample at its packaging plant tested positive for cronobacter sakazakii. In 2023, the FDA sent a warning letter to ByHeart detailing “areas that still require corrective actions,” and a plant in Reading, Pennsylvania, was shut down after inspectors found mold, water leaks, and insects.
In the wake of the outbreak, federal health officials have pledged to overhaul the U.S. food supply, with a renewed focus on infant formula safety. Health Secretary Robert F. Kennedy Jr. has ordered the FDA to conduct a comprehensive review of infant formula ingredients—the first such review since 1998. Dubbed “Operation Stork Speed,” this initiative will consider input from industry, health experts, and the public as the FDA determines next steps to ensure the safety and nutritional quality of formula for millions of American babies.
The ByHeart crisis has exposed vulnerabilities in the nation’s infant formula oversight, from manufacturing practices to recall effectiveness and public communication. As investigations continue and families seek answers, the hope is that lessons learned from this outbreak will lead to stronger protections for the country’s youngest and most vulnerable citizens.
