- Posted November 10, 2025
ByHeart Infant Formula Recalled Amid Botulism Outbreak, Investigation Continues
MONDAY, Nov. 10, 2025 (Health News) — Federal health officials have announced a recall for ByHeart Whole Nutrition Infant Formula after a multi-state outbreak of infant botulism.
Although botulism can be fatal, no deaths have been reported in the 10-state outbreak, according to the U.S. Food and Drug Administration (FDA).
Thirteen babies have been hospitalized with the illness since August.
The recall affects two lots of the powdered formula.
Parents should check their canisters for the following lot numbers and a Dec. 1 “use by” date: 206VABP/251261P2 and 206VABP/251131P2.
Infant botulism is a rare but serious condition caused by a toxin produced by Clostridium botulinum bacteria.
Symptoms may include constipation, poor feeding, difficulty swallowing, decreased facial expression and loss of head control, according to the U.S. Centers for Disease Control and Prevention (CDC).
Parents should seek immediate medical care if they notice any of these symptoms. It can take several weeks from the time of exposure for the illness to develop.
CDC also recommends that parents and caregivers wash all surfaces and utensils that may have come into contact with the recalled formula with hot soapy water or dishwasher cleaning.
To date, the cases have been identified in 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. The formula is sold nationwide and online.
Health officials are testing leftover formula samples to determine the precise point of contamination.
New York City-based ByHeart, which produces the organic, grass-fed whole milk formula, voluntarily removed the products from the market.
In a statement, the company said it was notified Nov. 7 that an estimated 83 cases of infant botulism nationwide have have been reported since August.
The company added that the FDA also noted that 13 infants had received ByHeart formula at some point.
"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 statement said.
Nonetheless, "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.
Treatment for infant botulism is available through an FDA-approved drug called BabyBIG, which uses antibodies to fight the toxins, NBC News reported.
More information
The U.S. Centers for Disease Control and Prevention (CDC) has more information regarding infant botulism symptoms.
SOURCES: U.S. Food and Drug Administration, announcement, Nov. 8, 2025; NBC News, Nov. 8, 2025
