ByHeart, which makes organic infant formula, 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.
ByHeart officials said parents and caregivers who have the formula in their homes “should immediately discontinue use and dispose of the product.”
Here’s what to know about the outbreak and infant botulism.
The outbreak begins
The outbreak has sickened babies age 2 weeks to 5 months since it started. The infants were hospitalized after consuming ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention.
California officials confirmed that a sample from an open can of ByHeart baby formula fed to an infant who fell ill contained the type of bacteria that causes the toxin linked to the outbreak. The tests to confirm contamination involve injecting mice with the cultured bacterium and then waiting up to four days to see if they get sick, said Dr. Erica Pan, the state health officer.
“These mice got sick really quickly,” Pan said in an interview.
ByHeart officials said they recalled their products “in close collaboration” with the U.S. Food and Drug Administration, despite the fact that no previously unopened product tested positive for the illness-causing bacteria. The type of bacteria that produces the toxin is widespread in the environment and could come from sources other than the formula, company officials said.
The FDA is investigating 84 cases of infant botulism detected since August. Of those, 15 consumed ByHeart formula, the agency said in a statement.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the agency said.
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.
