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A popular baby formula brand is recalling several batches of product amid a nationwide outbreak of infant botulism. ByHeart issued a voluntary recall of two batches of formula on Nov. 8 after receiving a notice from the U.S. Food and Drug Administration about an ongoing investigation into the recent outbreak. Per the FDA, the company was notified Nov. 7 about an estimated 83 cases of infant botulism that have been reported across the United States since August 2025, with 13 of those infants receiving formula from ByHeart at some point. In a statement on its website, ByHeart clarified, “It’s important to know that the FDA has never found a direct link between infant formula and infant botulism, and no related toxins have been found in any ByHeart product.” “Still, we decided to take this step to remove any potential risk from the market and ensure that the safety and well-being of every baby who uses ByHeart—including our own—will always come first,” the statement continued. Here’s everything to know about the voluntary recall, including which products have been affected and what to do if you purchased the products. Which Products Were Affected? The voluntary recall included two batches of the ByHeart Whole Nutrition Infant Formula, including: Batch Code: 251261P2, Use by: 01 Dec 2026 Batch Code: 251131P2, Use by: 01 Dec 2026 The UPC for both batches is 5004496800. The batch code can be found on the bottom of the can of formula. The formula is available for sale online and at major retailers nationwide. At this time, no other batches of ByHeart’s infant formula have been impacted by the recall. What Is Infant Botulism? Botulism is a rare, serious illness caused by a toxin that attacks the body’s nerves, according to the Centers for Disease Control. Primarily caused by the bacteria Clostridium botulinum, the bacteria can produce toxin in food, the intestines of infants and wounds. The bacteria make spores, which help bacteria survive, even under extreme conditions. While these spores typically do not make people sick, under certain conditions, they can grow and produce a lethal toxin. These conditions include: A certain amount of water A certain temperature range Low acid Low oxygen or no oxygen environments Low salt Low sugar The CDC reports that infant botulism can lead to conditions such as bulbar palsies, hypotonia or symmetric descending flaccid paralysis. Symptoms of infant botulism include: Constipation Diminished suck and gag reflexes Drooping eyelid Flatted facial expression Poor feeding Respiratory difficulty Weak cry If gone untreated, infant botulism can be life-threatening. Where Has the Botulism Outbreak Spread? A multi-state infant botulism outbreak is being investigated by the FDA and CDC in collaboration with the California Department of Public Health, Infant Botulism Treatment and Prevention Program as well as state and local partners. According to a Nov. 8 update, 13 infants with confirmed or suspected infant botulism cases have been reported in the following 10 states: Arizona California Illinois Minnesota New Jersey Oregon Pennsylvania Rhode Island Texas Washington All of the infants — who ranged in age from 16 to 157 days — were hospitalized and treated, but no deaths have been reported, per the CDC. Additionally, all 13 infants were given the now-recalled ByHeart formula. What To Do If You Bought the Recalled Product Any consumers who purchased the ByHeart infant formula from the listed batch codes should immediately stop using the product and dispose of the formula. ByHeart said that they will replace any discarded cans from the affected batches at no additional cost. If a consumer’s infant is experiencing symptoms related to botulism, they should contact their healthcare provider immediately. If any illness or adverse reaction occurs, consumers should call an FDA Consumer Complaint Coordinator or fill out a Voluntary MedWatch form.
