Preliminary tests showed that ByHeart baby formula contained the type of bacteria that produces the toxin linked to a botulism outbreak, California health officials stated.
The outbreak has affected at least 13 infants across 10 states, though no fatalities have been reported.
Consumers in possession of this product should stop using it immediately, according to a statement from the California Department of Public Health.
Further tests of ByHeart Whole Nutrition Infant Formula are pending as state and federal health officials investigate the outbreak which began in mid-August. The New York-based company has recalled two lots of the powdered product.
Infant Botulism Outbreak
The occurrence of infant botulism has affected babies aged 2 weeks to 5 months since mid-August, all of whom were hospitalized after consuming the ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention (CDC).
Cases related to the outbreak were reported in several states including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
California health officials tested a can of the formula that was given to a sick baby, suggesting the presence of the bacteria responsible for producing the botulism toxin, as confirmed in other cases. It may take several days to finalize these test results.
The FDA is currently investigating 83 reported cases of infant botulism linked to ByHeart baby formula since August.
Causes of Infant Botulism
Infant botulism typically affects fewer than 200 babies in the U.S. annually, stemming from a type of bacteria that produces toxins in the large intestine. This bacterium is dispersed through hardy spores found in the environment and can lead to serious illness, including paralysis, particularly in infants under one year old.
Symptoms may take weeks to manifest and can include poor feeding, loss of head control, drooping eyelids, and a flat facial expression.
Treatment and Impact
The only known treatment for infant botulism is an IV medication called BabyBIG, which is made from pooled blood plasma of adults immunized against botulism. All affected children have received this treatment according to the CDC.
Despite the outbreak, state and federal authorities say that there is no danger of a national formula shortage, as ByHeart comprises only about 1% of total formula sales in the U.S. The recent incident is starkly different from the crisis tied to Abbott formula in 2022, which led to significant nationwide shortages.
