A sudden outbreak of infant botulism has forced ByHeart, a New York-based maker of organic baby formula, to recall all of its formula products nationwide, shaking parents and health officials alike. The recall, announced on November 11, 2025, comes as federal and state agencies investigate a growing number of infant illnesses potentially linked to ByHeart’s Whole Nutrition infant formula. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are leading the inquiry, which spans twelve states and has already resulted in the hospitalization of fifteen infants.
The affected babies, ranging in age from just 16 days to five months, were all exposed to ByHeart powdered formula, according to the CDC. Each of these infants was hospitalized and received BabyBIG, an intravenous antibody treatment developed specifically for infant botulism by California’s Infant Botulism Treatment and Prevention Program. Thankfully, as of the latest reports, no deaths have been attributed to the outbreak.
The outbreak, which began in mid-August, has left parents reeling and health officials scrambling for answers. As of November 10, cases had been reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Nine cases have been confirmed as type A infant botulism, with six others still awaiting final laboratory results, according to Dr. Erica Pan, California’s state public health officer.
Botulism is a rare but serious illness caused by Clostridium botulinum, a bacterium that produces a potent neurotoxin. Infants are particularly vulnerable because their developing gut microbiomes can’t yet fend off the spores that cause the disease. Symptoms, which may take weeks to appear, include constipation, poor feeding, loss of head control, drooping eyelids, a weak or altered cry, and, in severe cases, difficulty breathing or even respiratory arrest. “Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time,” Dr. Pan explained in a press release.
The FDA said that since August, 84 infants nationwide have been treated for infant botulism, with 43% of those cases involving exposure to powdered infant formula. Of those infants, more than 40% had consumed ByHeart Whole Nutrition formula, a disproportionate figure given that ByHeart accounts for only about 1% of national formula sales. “This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the FDA stated.
As the investigation unfolded, California officials confirmed on November 8 that a sample from an open can of ByHeart formula fed to one of the sick infants tested positive for the botulism-causing bacteria. The confirmation process involved injecting mice with the cultured bacterium and observing whether they developed symptoms. “These mice got sick really quickly,” Dr. Pan noted, underscoring the urgency of the situation.
Despite these findings, the FDA emphasized that, as of November 11, no unopened cans of ByHeart formula had tested positive for Clostridium botulinum spores or toxins. Still, the agency and ByHeart both urged parents and caregivers to immediately discontinue use and dispose of any ByHeart formula they might have at home. “At this moment, the most important thing for you to know is that all ByHeart product must be discarded. We know that switching formulas is not an easy process or decision. We have resources to help,” wrote Mia Funt and Ron Belldegrun, ByHeart’s co-founders, in an online letter to families. “We are so sorry, and are committed to doing anything we can to support you.”
ByHeart said it was cooperating fully with the FDA, providing unrestricted access to its facilities and products for ongoing testing. The company also recalled two specific lots of its Whole Nutrition Infant Formula—206VABP/251261P2 and 206VABP/251131P2, both with best-by dates of December 2026—before extending the recall to all of its formula products. “Testing unopened cans will provide reliable evidence that will help bring clarity to families who are understandably concerned,” the company stated, as cited by Food Manufacturing.
For now, the FDA and CDC have not identified any other infant formula brands or shared exposures as posing a risk to infants. The agency continues to analyze samples from several states, with further laboratory results expected in the coming weeks. Meanwhile, parents are being urged to remain vigilant for signs of illness in their infants and to seek immediate medical attention if any symptoms arise.
Infant botulism remains a rare disease in the United States, typically affecting fewer than 200 babies annually. The only treatment, BabyBIG, is both rare and expensive—each vial costs about $69,300, according to Dr. Pan. The medication, derived from the blood plasma of adults immunized against botulism, is the sole product of its kind worldwide and is credited with shortening hospital stays and reducing the severity of illness in affected infants. Because botulism can impair an infant’s ability to breathe, many of the sickened babies required ventilator support during their hospitalizations.
Despite the recall, experts and officials say there is little risk of a nationwide formula shortage. ByHeart’s relatively small market share—about 1%—means the impact on overall supply is minimal. This stands in stark contrast to the formula crisis of 2021 and 2022, when a separate outbreak linked to Abbott Nutrition led to the closure of a major plant and a months-long shortage across the country. Notably, ByHeart itself recalled five batches of formula in 2022 after a sample tested positive for cronobacter sakazakii, the germ at the heart of the Abbott crisis. In 2023, the FDA issued a warning letter to ByHeart, citing “areas that still require corrective actions.”
The current crisis has prompted renewed scrutiny of infant formula safety and the regulatory framework overseeing it. Health Secretary Robert F. Kennedy Jr. recently launched “Operation Stork Speed,” directing the FDA to undertake its first comprehensive review of infant formula ingredients since 1998. The review aims to assess nutrient content and other ingredients, with input from industry representatives, health experts, and the public. FDA officials are now weighing these comments to determine future regulatory steps.
For parents, the news is both alarming and confusing. With no deaths reported and all affected infants receiving prompt treatment, the immediate health risk appears to be contained. Still, the episode has exposed vulnerabilities in the nation’s food safety system and highlighted the importance of swift, transparent communication between manufacturers, regulators, and families.
As the investigation continues and more test results come in, parents and caregivers are left to navigate a rapidly evolving situation—one that, for now, serves as a sobering reminder of the stakes involved in feeding the country’s youngest and most vulnerable.
