More than three dozen babies have become sick in an infant botulism outbreak linked to ByHeart powdered formula, according to the Food and Drug Administration.
Federal officials said Wednesday that 37 confirmed or suspected cases have been reported in infants who consumed the New York-based company’s formula since August.
The most recent case was logged on Nov. 19, and no deaths have been reported.
The FDA publicly announced the outbreak on Nov. 8.
ByHeart recalled every can of formula it sold in the United States on Nov. 11.
The company typically accounts for about 1% of the nation’s formula market and has been selling roughly 200,000 cans per month.
California health officials previously confirmed that an open can of ByHeart formula fed to a sick infant contained the bacteria that can cause botulism.
ByHeart has said laboratory testing also detected contamination in additional samples.
FDA inspectors have visited the company’s production sites in Allerton, Iowa, and Portland, Oregon, as part of the ongoing investigation.
The agency said ByHeart formula is “disproportionately represented among sick infants in this outbreak.”
Illnesses began between Aug. 9 and Nov. 19. Cases have been reported in 17 states: Arizona, California, Idaho, Illinois, Kentucky, Maine, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin.
All affected babies, ranging from about 2 weeks to 9 months old, were hospitalized after drinking ByHeart powdered formula.
Families of several infants have filed lawsuits in federal court, alleging the formula was defective and that the company acted negligently.
The suits seek compensation for medical treatment, emotional distress, and other impacts.
Infant botulism is rare—typically fewer than 200 U.S. cases a year—but serious.
As of Sept. 20, there had been 133 cases reported nationwide, nearing last year’s total of 145.
The illness occurs when spores of a specific bacterium germinate in the large intestine and produce a toxin.
Infants are especially vulnerable because their gut microbiomes are not yet mature enough to block germination.
Exposure can come from contaminated dust, dirt, water, or honey, and symptoms can take up to 30 days to appear.
Signs can include poor feeding, weak muscle tone, drooping eyelids, difficulty swallowing, loss of facial expression, and trouble breathing. Babies often appear “floppy,” doctors say.
While powdered infant formula has been connected to isolated cases in the past, researchers have not previously documented a confirmed outbreak associated with a formula product.
The only treatment for infant botulism is BabyBIG—an IV medication developed through California’s infant botulism program from plasma donated by adults immunized against the toxin.
It is the sole source worldwide and is used to reduce the severity of illness and shorten hospital stays.
Because the toxin can impair breathing, infants frequently require ventilator support.
Officials say the recall is not expected to disrupt national formula availability because ByHeart holds a small share of the market.
That sharply contrasts with the 2021–22 supply crisis, when Abbott Nutrition recalled major brands during a separate investigation involving a different germ, Cronobacter sakazakii.
Although no direct link was found between Abbott’s formulas and those infections, the FDA closed the company’s Michigan plant after contamination and other issues were identified, leading to months-long shortages.
ByHeart itself previously recalled five batches of formula in 2022 after a packaging plant sample tested positive for Cronobacter sakazakii.
In 2023, the FDA issued a warning letter to the company addressing needed corrective actions.
Inspectors later found mold, water leaks, and insects at a ByHeart facility in Reading, Pennsylvania, according to agency records.
In response to recent safety issues across the industry, Health Secretary Robert F. Kennedy Jr. has directed the FDA to reevaluate infant formula ingredients for the first time since 1998.
The effort—called “Operation Stork Speed”—is gathering input from formula companies, medical experts, and the public.
FDA officials are currently reviewing the feedback before deciding next steps.
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