ByHeart voluntarily recalls two batches of Whole Nutrition Infant Formula amid an FDA investigation into a nationwide outbreak of infant botulism.
No ByHeart products have tested positive for contamination, and the FDA has not found a direct link between any infant formula and the reported cases.
The company says the recall is a precautionary measure driven by transparency and its commitment to infant safety.
ByHeart, a baby nutrition company, is recalling two batches of its Whole Nutrition Infant Formula after being notified by the U.S. Food and Drug Administration (FDA) of an ongoing investigation into a national outbreak of infant botulism.
The recall, issued “out of an abundance of caution,” affects two specific production batches — 251261P2 and 251131P2, both with a “Use By” date of December 1, 2026. No other batches are impacted.
The company emphasized that no ByHeart formula has tested positive for Clostridium botulinum spores or toxins, and the FDA has not established any link between infant formula and the reported illnesses.
The FDA informed ByHeart on last week that approximately 83 cases of infant botulism had been reported across the U.S. since August. Of those, 13 infants had consumed ByHeart formula at some point. However, officials clarified that there is no historical precedent of infant formula causing infant botulism.
Rare, but serious
Botulism in infants, though rare, is a serious and potentially fatal illness that occurs when Clostridium botulinum spores colonize an infant’s intestinal tract, producing neurotoxins. Symptoms can include constipation, weak muscle tone, drooping eyelids, difficulty feeding or swallowing, a weak cry, and in severe cases, respiratory distress or arrest.
The bacteria are typically found in environmental sources such as soil, dust, and certain vegetables, not dairy-based products or infant formula.
“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, ByHeart’s co-founder and president. “We take any potential safety concern extremely seriously, and act quickly to protect families. 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.”
Funt stressed that no testing by ByHeart or any regulatory agency has confirmed contamination in its products. The recall, she said, reflects the company’s proactive stance on infant health rather than a confirmed safety breach.
What parents should do
The company said consumers who purchased ByHeart formula from the affected batches should stop using the product immediately and dispose of it safely. ByHeart has pledged to replace any discarded cans at no cost.
Parents whose infants exhibit symptoms of botulism should contact a healthcare provider right away. To report illness or an adverse event, consumers can:
Call an FDA Consumer Complaint Coordinator
File an electronic MedWatch form online, or
Submit a paper MedWatch report by mail.
Customers can reach ByHeart’s 24/7 support line at 1-833-429-4327 or email hello@byheart.com for assistance. More information is available at byheart.com.