ByHeart Inc. is voluntarily recalling two lots of its Whole Nutrition Infant Formula after 13 infants across 10 states developed botulism, a rare and potentially deadly illness caused by bacterial toxins.
All 13 babies — ranging from 16 to 157 days old — required hospitalization and treatment with BabyBIG®, an antitoxin administered intravenously. No deaths have been reported.
The recalled lots are 206VABP/251261P2 and 206VABP/251131P2, both of which carry a best-by date of December 2026. The UPC is 5004496800. Cases have been confirmed in Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington.
“The safety and well-being of every infant who uses our formula is our absolute highest priority,” ByHeart co-founder and president Mia Funt said in a statement. “We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents.”
The Centers for Disease Control and Prevention stated that every affected family reported feeding their infant the ByHeart product in the month preceding the onset of symptoms. Illness onset dates from mid-August to early November.
California health officials said preliminary testing of an opened container from one case “suggest the presence” of Clostridium botulinum, the bacterium that produces the botulism toxin, the Associated Press reported. Full laboratory results are pending.
Parents who have the recalled formula should immediately stop using it, photograph the lot code, then discard or return the product. The CDC recommends cleaning any bottles or surfaces that came in contact with the powder with hot, soapy water or a dishwasher.
Watch for warning signs, including constipation, poor feeding, drooping eyelids, a weak cry, difficulty swallowing, loss of head control, or a flat facial expression.
Symptoms may appear up to several weeks after exposure.
ByHeart, a New York-based company founded in 2016, holds approximately 1% of the U.S. formula market and sells its products through its website and major retailers. The FDA said the recall will not trigger nationwide shortages.
The agency is working to pinpoint the source of contamination and determine whether additional lots are affected. Testing of unopened product from the two lots is underway.
Infant botulism strikes fewer than 200 U.S. babies annually and has never before been tied to powdered formula, according to experts.