ByHeart baby formula recalled amid 10-state outbreak of infant botulism
- - ByHeart baby formula recalled amid 10-state outbreak of infant botulism
Dennis RomeroNovember 9, 2025 at 1:06 AM
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A maker of organic baby formula is recalling some of the product after federal officials linked it to a 10-state infant botulism outbreak.
The U.S. Food and Drug Administration said the outbreak includes 13 hospitalizations since August of children who consumed ByHeart Whole Nutrition Infant Formula.
No deaths have been reported.
A container of ByHeart Whole Nutrition Infant Formula, subject of a recall following an infant botulism outbreak. (U.S. Food and Drug Administration)
The recall includes two lots of the powdered formula with Dec. 1 “use by” dates, the FDA said in a statement Saturday. The lot numbers are 206VABP/251261P2 and 206VABP/251131P2.
The FDA asked parents and caregivers who have the product to record identifying information at the bottom of the packaging and promptly throw it away. It said it was working with retailers to remove “all potentially impacted product” from store shelves.
Infant botulism is a bacteria-produced toxin that can cause constipation, poor feeding, loss of head control, difficulty swallowing and can ultimately lead to paralysis and death, according to the Centers for Disease Control and Prevention.
The FDA said parents and caregivers who have fed ByHeart to children recently should keep a close eye on them as a precaution, as botulism can take weeks to develop.
Infant botulism cases linked to the ByHeart formula have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, the agency said.
In a statement, New York City-based ByHeart said it was told on Friday that the FDA had tracked an estimated 83 reports of infant botulism across the nation since August and that 13 babies had consumed the formula. It said government tests and its own had yet to turn up botulism in its product.
"ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants," the company said. "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 said officials in several states are testing leftover formula and that the results are expected to be available in the coming weeks. The agency said it is trying to determine "the point of contamination and if any additional products are impacted."
California Department of Public Health officials, separately, reported an increase in infant botulism among babies who consumed ByHeart since August, the FDA said.
ByHeart focuses on healthier food for infants made with organic, grass-fed whole milk which it says is closer in composition to breast milk, according to the company's website. It says its facilities in Iowa, Pennsylvania and Oregon produce formula sold at nearly 12,000 retailers.
The FDA says ByHeart makes up less than 1% of the baby formula sold in the U.S.
Infant botulism can be treated with BabyBIG, an FDA-approved "orphan drug" that consists of antibodies to fight botulinum neurotoxins, according to the California Department of Public Health.
Source: “AOL Breaking”
