(NewsNation) — The infant organic formula company ByHeart has recalled all of its products sold throughout the U.S. on Tuesday amid a growing outbreak of infant botulism.
At least 15 babies in 12 states have been sickened in the outbreak tied to ByHeart formula, state and federal health officials said. That’s an increase from 13 cases in 10 states reported Saturday.
No deaths have been reported in the outbreak, which began in August.
“We are so sorry for the immense anxiety and fear that we have been causing you these past few days. As parents and as founders, that is the absolute last thing we would ever want to do,” a statement from the company read in part.
ByHeart officials said parents and caregivers who have the formula in their homes “should immediately discontinue use and dispose of the product.”
Infants with botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, but these symptoms can progress to difficulty breathing and respiratory arrest, the FDA said.
Symptoms can take as long as several weeks to develop following formula ingestion.
Illnesses began between Aug. 9 and Nov. 10, federal officials said. Cases were reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak, officials said.