As of November 10, 15 infants have been reported with suspected or confirmed infant botulism due to exposure to Byheart Whole Nutrition Infant Formula across 12 states according to the U.S. Food and Drug Administration.
There is one suspected case currently under investigation in North Carolina.
As of Nov. 11, all lots of ByHeart Inc. Whole Nutrition Infant Formula have been voluntarily recalled with investigations ongoing.
No deaths have been reported in the outbreak, which began in mid-August.
ByHeart officials said parents and caregivers who have the formula in their homes "should immediately discontinue use and dispose of the product."
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.
"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 unopened ByHeart product" tested positive for the illness-causing bacteria.
The FDA is investigating 84 cases of infant botulism detected since August. Of those, 36 consumed infant formula - more than a third of them ByHeart's 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 FDA said.
SEE ALSO: NC family loses more than $6,000 after trying to confirm airline seats, learns it was fake email