Baby formula recall expands as botulism outbreak linked to ByHeart has sickened at least 15 infants, officials say
An outbreak of botulism linked to ByHeart baby formula has affected at least 15 infants in 12 states, according to a California health official on Monday. The company has announced an expansion of its voluntary recall to include all products while investigations are ongoing.
Dr. Erica Pan, health officer for the California Department of Public Health, confirmed nine cases of infant botulism type A, with results pending for six others. This marks an increase from the 13 cases reported in 10 states over the weekend. The outbreak, which began in mid-August, is being investigated by federal and state officials, with no reported deaths so far.
ByHeart, a New York-based maker of organic baby formula, initially recalled two lots of its Whole Nutrition Infant Formula over the weekend. The recall has now been expanded to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs nationwide.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” said Mia Funt, co-founder and president of ByHeart in a statement. The company is conducting a comprehensive investigation to provide clear information to families affected by the recall.
Consumers in possession of the affected product are advised to stop using it immediately, according to California officials. The outbreak has affected infants aged 2 weeks to 5 months who were hospitalized after consuming ByHeart powdered formula, as reported by the U.S. Centers for Disease Control and Prevention.
Tests confirmed the presence of the toxin-producing bacteria in a sample from an open can of ByHeart baby formula fed to an ill infant. ByHeart officials have called for testing of unopened cans to provide reliable evidence for concerned families.
Infant botulism is a rare condition affecting fewer than 200 babies in the U.S. each year. It is caused by a bacterium that produces a toxin in the large intestine, leading to serious illness including paralysis. Symptoms may include poor feeding, loss of head control, drooping eyelids, and difficulty swallowing or breathing.
The only treatment for infant botulism is BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. All children in the ByHeart outbreak have received this treatment, which aims to shorten hospital stays and reduce illness severity.
While there is little risk of infant formula shortages due to this outbreak, federal health officials are reevaluating the U.S. food supply, including infant formula ingredients. The FDA’s “Operation Stork Speed” is the first comprehensive review of infant formula ingredients since 1998, with industry feedback and public input guiding next steps.
