Additional Coverage:
Organic Baby Formula Recalled Amid Infant Botulism Outbreak
A producer of organic baby formula has initiated a recall of some of its products after federal authorities connected them to an infant botulism outbreak spanning ten states.
The U.S. Food and Drug Administration (FDA) reported that the outbreak involves 13 hospitalizations since August, all linked to children who consumed ByHeart Whole Nutrition Infant Formula. Fortunately, no fatalities have been reported.
The recall specifically targets two lots of the powdered formula with a “use by” date of December 1st. The affected lot numbers are 206VABP/251261P2 and 206VABP/251131P2.
The FDA advises parents and caregivers who possess these products to record the identifying information from the bottom of the packaging and then dispose of them immediately. The agency is also collaborating with retailers to ensure all potentially affected products are removed from store shelves.
Infant botulism is a serious condition caused by a bacteria-produced toxin. Symptoms can include constipation, poor feeding, loss of head control, difficulty swallowing, and in severe cases, it can lead to paralysis and even death, according to the Centers for Disease Control and Prevention (CDC). Given that botulism can take weeks to manifest, the FDA recommends that parents and caregivers who have recently fed ByHeart formula to their children closely monitor them for any symptoms as a precautionary measure.
Cases of infant botulism linked to ByHeart formula have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
ByHeart, a New York City-based company, stated that they were informed by the FDA on Friday about an estimated 83 infant botulism reports nationwide since August, with 13 of those babies having consumed their formula. The company emphasized that both government and its own tests have not yet detected botulism in its products.
In a statement, ByHeart affirmed, “ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants. The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.”
The FDA confirmed that officials in several states are currently testing leftover formula, with results anticipated in the coming weeks. The agency is actively working to pinpoint “the point of contamination and if any additional products are impacted.” Separately, officials from the California Department of Public Health have also reported an increase in infant botulism cases among babies who consumed ByHeart formula since August.
ByHeart focuses on producing healthier infant food made with organic, grass-fed whole milk, aiming for a composition similar to breast milk. The company’s facilities in Iowa, Pennsylvania, and Oregon supply formula to nearly 12,000 retailers. The FDA notes that ByHeart accounts for less than 1% of the baby formula sold in the U.S.
For those affected, infant botulism can be treated with BabyBIG, an FDA-approved “orphan drug” containing antibodies designed to combat botulinum neurotoxins, as per the California Department of Public Health.