More than three dozen infants have been affected by an outbreak of infant botulism linked to contaminated formula, according to federal health officials. The Food and Drug Administration (FDA) reported 37 cases of confirmed or suspected illness in babies who consumed ByHeart formula since August, with the most recent case reported on November 19. No deaths have been reported.
ByHeart, a New York-based manufacturer of organic infant formula, recalled all its products sold in the United States on November 11 after the outbreak was announced on November 8. The company had been selling about 200,000 cans per month and accounts for approximately 1% of the U.S. infant formula market.
The FDA stated that symptoms of infantile botulism can take up to 30 days to develop. The affected infants range from about two weeks to nine months old and were hospitalized after consuming ByHeart powdered formula.
California officials confirmed that a sample from an open can of ByHeart baby formula fed to a sickened infant contained bacteria capable of causing illness. Lab tests conducted by the company also confirmed contamination in some samples. FDA inspectors have visited ByHeart’s production plants in Allerton, Iowa, and Portland, Oregon.
The agency noted that “ByHeart brand formula is disproportionately represented among sick infants in this outbreak.” Illnesses began between August 9 and November 19 across several states including Arizona, California, Idaho, Illinois, Kentucky, Maine, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin.
Families whose children became ill after drinking ByHeart formula have filed lawsuits against the company in federal courts. These suits allege that the product was defective and that ByHeart was negligent in its sale. Plaintiffs are seeking compensation for medical bills and emotional distress.
Infant botulism is rare in the United States with fewer than 200 cases typically reported each year. As of September 20 this year there were 133 cases recorded; last year saw a total of 145 cases according to Centers for Disease Control and Prevention data. The infection is caused by bacteria producing toxins in the large intestine—spread through spores found in dust or dirt—or through contaminated food such as honey or formula.
Symptoms may take weeks to appear and include poor feeding habits as well as muscle weakness such as loss of head control or drooping eyelids. Treatment involves BabyBIG—an intravenous medication developed by California’s infant botulism program—which shortens hospital stays but often requires ventilator support due to breathing difficulties.
Despite concerns about supply disruptions following this recall there is little risk of nationwide shortages because ByHeart holds only a small share of the market. This situation differs from events in late 2021 and early 2022 when Abbott Nutrition recalled top brands after four infants were sickened by another germ; two died but no direct link was established between their products and infections.
In previous years ByHeart has faced recalls and regulatory scrutiny: five batches were recalled in 2022 due to cronobacter sakazakii contamination at a packaging plant; a warning letter from the FDA followed in 2023 citing unresolved issues; inspection documents show mold and water leaks at its Reading facility before it was shut down just prior to another inspection.
Federal health authorities are now reviewing regulations around infant formula ingredients under Health Secretary Robert F. Kennedy Jr.’s direction—a process named “Operation Stork Speed”—which represents the first comprehensive review since 1998.
