Fifteen infants, including one in Pennsylvania and one in New Jersey, have ben hospitalized during a botulism outbreak linked to ByHeart Whole Nutrition Infant Formula.
ByHeart voluntarily recalled all of its baby formula products Tuesday, an expansion of an initial recall, issued last weekend, that included two batches of formula. Infant botulism affects babies' digestive and nervous systems and can be fatal. No infant deaths have been reported.
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"The safety and well-being of every infant who uses our formula is, and always will be, our highest priority," ByHeart President Mia Funt said in a statement Tuesday. "This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve."
The Pennsylvania Department of Health is supporting the ongoing investigation into the 12-state outbreak by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, state health officials said Monday.
The FDA notified ByHeart on Friday of 84 infant botulism cases that have been reported nationwide since August, Funt said. On Thursday, preliminary lab results reported by the California Department of Public Health suggested that bacteria that produce botulism toxin were present in an open can of ByHeart formula that had been fed to a baby who developed botulism, the FDA said.
Parents and caregivers are directed to stop using and throw out all ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs, the FDA said.
Infant botulism usually occurs in babies under 1 who ingest the bacteria Clostridium botulinum. Symptoms may include choking when trying to feed, constipation, weaker suck or poor feeding, eyelid drooping, lack of facial expressions, weaker crying and muscle weakness, making babies feel "floppy," according to the Cleveland Clinic.
Babies experiencing any of these symptoms should get immediate medical attention, the Pennsylvania health department said.
ByHeart formula makes up less than 1% of the formula products on the market and will not cause a shortage, the FDA said.