Submitted on Wed, 11/12/2025 - 09:05
All ByHeart infant formula nationwide has been recalled after 15 children who consumed the products were diagnosed with infant botulism, the company announced Tuesday.
Company officials and the Food and Drug Administration (FDA) announced Nov. 11 that families should stop using all ByHeart formula immediately. The FDA recommended a full recall after 15 infants in 12 states had been hospitalized and treated for suspected or confirmed cases of infant botulism since mid-August. No deaths have been reported.
The FDA also confirmed that the Infant Botulism Treatment and Prevention Program has treated 69 additional children with infant botulism since Aug. 1, though it did not specify sources of those infections.
Parents should remain confident in the safety of the country’s formula supply, said Steven A. Abrams, M.D., FAAP, former chair of the AAP Committee on Nutrition and member of the Section on Neonatal-Perinatal Medicine.
“ByHeart is a relatively small part, about 1%, of the U.S. formula market, and this recall does not put the overall availability of infant formula in the country at risk,” Dr. Abrams said. “Baby formula made and sold in the U.S. is tightly regulated and safe.”
ByHeart initially recalled two lots of infant formula but extended it to include all of its products, including cans and single-serve sticks.
“The total number of botulism cases among infants in the U.S. seems to be higher in recent months, but a full investigation into this will need to be undertaken before any causes can be identified,” Dr. Abrams said.
The 15 suspected or confirmed cases were identified in Arizona, California, Illinois, Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas and Washington and involved infants ages 16-157 days, according to the FDA.
“Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants,” the FDA said in a news release.
ByHeart said it gave the FDA access to its facilities and products for testing and is conducting its own testing.
The FDA said consumers with ByHeart formula should:
- take a photo of or record the information on the bottom of the can,
- keep the container in a safe place and clearly label it “DO NOT USE,”
- be prepared for the state health department to contact them and collect formula for testing if their child develops infant botulism symptoms within 30 days of the recall and
- dispose of formula after 30 days.
The Centers for Disease Control and Prevention advises parents to wash items and surfaces that may have come into contact with the recalled formula using hot, soapy water or a dishwasher.
Tips on choosing a baby formula are available from HealthyChildren.org at https://bit.ly/47MklAH. ByHeart posted information regarding switching baby formulas at https://bit.ly/4povCP9.
ByHeart said no unopened cans of formula have tested positive for Clostridium botulinum, the bacteria that causes infant botulism. The California Department of Public Health confirmed that one previously opened sample of formula from the recalled batches tested positive.
“Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product,” the FDA said.
Publisher:American Academy of Pediatrics
