Formula recalled in Pa. after infant botulism outbreak

Pennsylvania is one of 12 states included in an outbreak of infant botulism — linked to ByHeart Whole Nutrition Infant Formula.

Parents and caregivers should stop using any ByHeart infant formula products “immediately,” Allegheny County said Friday in an announcement, as all of its products have been recalled. The recall includes all unexpired lots of formula cans and single-serve “anywhere” sticks.

A Pennsylvania plant run by the company ByHeart was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects inside a food production area, the New York Times reported.

Botulism can be fatal, and action should be taken “immediately” to seek medical attention if a child has consumed ByHeart Whole Nutrition Infant Formula, the county said.

Symptoms can include poor feeding, loss of head control, difficulty swallowing or decreased facial expression.

Most babies with infant botulism will initially develop constipation, poor feeding, loss of head control and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest.

Infant botulism is diagnosed clinically, the county said, and it can take as long as several weeks to develop following formula ingestion.

“At this time, no deaths have been reported, and there are currently no suspected cases in Allegheny County,” a county statement said. “If the child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.”

Physicians who suspect an infant has botulism should immediately call the Infant Botulism Treatment and Prevention Program at 510-231-7600 for case consultation that’s available 24/7. All suspected cases should be reported to the health department by calling 412-687-4423.

For those who still have the formula in their home, they should take a photo or record the information on the bottom of the package, keep the container in a safe spot and label the product “DO NOT USE,” according to the county.

If their child develops symptoms, the Allegheny County Health Department will arrange for collection and testing of the formula. If they don’t develop symptoms, the containers can be thrown out after 30 days.

The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration are investigating the outbreak alongside state and local health departments to determine the contamination source, the county said.

The CDC National Botulism Surveillance System records approximately 150-180 infant botulism cases each year.

ByHeart infant formula products make up less than 1% of all infant formula sold in the United States, the county said, and because of this, the outbreak hasn’t created shortage concerns of infant formula.