Recall Widens for Baby Formula Linked to Infant Botulism

All formula made by the manufacturer have now been recalled, federal authorities announced.

ByHeart infant formula. FDA

The recall for baby formula linked to a rare illness in infants has widened, the Food and Drug Administration and Centers for Disease Control and Prevention said on Nov. 11.

All formula products made by the company ByHeart have now been recalled, according to the FDA.

“FDA has been in contact with the firm and has requested a recall expansion to include all ByHeart infant formula on the market,” the FDA and CDC said in a joint statement. “On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks.”

The development comes after a sample from the formula tested positive for the bacteria that cause infant botulism, a rare disease that can cause severe symptoms such as difficulty swallowing.

The number of infants with confirmed or suspected botulism after consuming ByHeart’s formula is now up to 15, across 12 states. All the infants have been hospitalized. No deaths have been reported to date.

The states with at least one case are: Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

ByHeart, based in New York, makes about 1 percent of the baby formula sold domestically.

ByHeart products, including a 24-ounce can and 0.6-ounce sticks, are sold in retail stores and online.

ByHeart previously recalled lots it said may be associated with the outbreak. It had said it took the positive test results seriously while urging authorities to test unopened cans to help figure out whether the formula is causing the botulism cases.

In a statement on Monday, the company said that the expanded recall “reflects our commitment to protecting babies and giving families clear, actionable information” and was being coupled with “a comprehensive investigation to do our part to get the answers parents expect and deserve.”

The company is having an independent laboratory test its formula, providing the FDA and California officials with full access to its facilities and unopened cans, and pledging to share the test results as they become available.

Approximately 69 other infants have been treated in the United States since Aug. 1 for botulism and have not had confirmed exposure to ByHeart’s formula, authorities said.

“Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants,” the FDA and CDC said.

Acting CDC Director Jim O'Neill wrote on X that people should immediately stop using ByHeart infant formula.

“Seek urgent medical care if infant shows: poor feeding, loss of head control, difficulty swallowing, or decreased facial expressions,” he said.