Case of infant botulism reported in Kentucky amid baby formula recall
A case of a rare infant disease has been reported in Kentucky amid a nationwide recall of a baby formula brand, according to the Centers for Disease Control and Prevention and the Food and Drug Administration.
As of Friday, there have been 23 infants with suspected or confirmed infant botulism across 13 states, including Kentucky. Infant botulism is a life-threatening condition that can cause paralysis in infants, according to the Cleveland Clinic.
There were no details available about the infant botulism case in Kentucky. Kendra Steele, a spokesperson for the Kentucky Cabinet for Health and Family Services, said the case has not been confirmed at this time, and the Kentucky Department for Public Health is investigating.
The CDC said all 23 infants with the disease were hospitalized and treated, and no deaths have been reported.
Infant botulism happens when a baby swallows Clostridium botulinum spores that can make toxin in a baby’s digestive system, according to the Cleveland Clinic. FDA officials believe ByHeart Whole Nutrition infant formula might be contaminated with the bacteria, but there have been no positive tests of the bacteria in unopened ByHeart products.
All 23 infants with botulism were exposed to ByHeart products, according to the FDA. ByHeart voluntarily recalled all of its products Nov. 11.
The Kentucky infant suspected of having botulism is younger than four months old, Steele said, and consumed ByHeart formula. KDPH is not releasing the location of the suspected case.
Three days before the recall, the California Department of Public Health found evidence of the botulinum toxin in an open can of ByHeart formula that was fed to an infant with infant botulism, the FDA said. Additional testing is ongoing.
“The safety and wellbeing of every infant who uses our formula is, and always will be, our highest priority,” Mia Funt, co-founder and president of ByHeart, said in a news release. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information.”
Parents and caregivers are encouraged to stop using ByHeart infant formula products immediately, the FDA said. Anyone with ByHeart formula is asked to record the information on the bottom of the package and keep it in a safe spot in case it’s needed for testing.
If a child does not develop symptoms after 30 days of exposure, parents should throw out the containers, the FDA said.
Symptoms of infant botulism can include choking during feeding, weaker sucking or crying, constipation, drooping eyelids, lack of facial expressions and decreased muscle tone. The Cleveland Clinic said babies with botulism will be alert, won’t have a fever and will act healthy otherwise.
Infant botulism primarily affects babies younger than 1, according to the Cleveland Clinic. The age range for 22 of the infected infants is between 16 and 200 days, according to the CDC.
This story was originally published November 17, 2025 at 12:29 PM.
