(NewsNation) — The scope of an infant botulism outbreak linked with the ByHeart baby formula brand has widened, and federal regulators say the manufacturer’s products may have been tainted since they first went on sale in March 2022.
As of Wednesday, Dec. 10, at least 51 infants in 19 states are believed to have become ill from ByHeart formula dating back to at least December 2023, the Food and Drug Administration said in an update.
The agency added it “cannot rule out the possibility that contamination might have affected all ByHeart formula products.” The Centers for Disease Control and Prevention has broadened the case definition to include infants exposed to ByHeart formula “since the product’s release in March 2022,” the FDA said.
Previously, officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August 2025. But The Associated Press interviewed parents who said their infants became ill prior to that date after consuming ByHeart products.
All 51 infants who became ill — ranging in age from 16 to 264 days — were hospitalized, but no deaths have been reported, officials said.
Initial symptoms of infant botulism include constipation, poor feeding, loss of head control and difficulty swallowing, the CDC says.
ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all of its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.
The company’s last statement about its recall and how to obtain refunds is dated Nov. 24 on its website.
Investigations into the cause of the outbreak continue, the FDA said.
The Associated Press contributed to this report.