The nationwide infant formula crisis has deepened, with 31 babies now hospitalized for botulism after consuming ByHeart formula products, federal health officials confirmed Wednesday. The affected infants, ranging from just two weeks to six months old, span 15 states in what’s quickly becoming one of the most concerning infant formula safety incidents since the 2022 shortages.
Recalled Formula Still on Store Shelves
Despite a nationwide recall announced more than a week ago, investigators have found ByHeart’s potentially contaminated formula still available for purchase across multiple states. In Oregon, nine stores out of more than 150 checked still had the recalled products on shelves, while Minnesota officials discovered and removed products from four locations after conducting 119 store checks between November 13 and 17. Arizona health officials have similarly reported finding the recalled formula still available for sale.
“We want parents and caregivers to know that we are working closely with our federal partners to understand the extent of this outbreak and ensure that affected products are removed from circulation,” said Dr. Christine Hahn, Idaho state epidemiologist, in a statement after confirming Ada County’s first case linked to the outbreak.
The formula, which retails for about $42 per can, was being produced at a rate of approximately 200,000 cans monthly and distributed both online and through major retailers including Target and Walmart. A Walmart spokesperson indicated the company had quickly restricted sales, removed products from stores, notified consumers, and is offering refunds for any purchased cans.
How the Investigation Unfolded
The outbreak first gained attention when the FDA notified ByHeart on November 7, 2025, about an estimated 83 cases of infant botulism reported nationwide since August. By November 8, the CDC had identified 13 infants with confirmed or suspected botulism across 10 states who had consumed the formula.
Though ByHeart initially recalled only two specific lots, the company subsequently expanded the recall to include all infant formula products nationwide “in close cooperation” with the FDA. The decision came despite the company’s assertion that “no unopened ByHeart product has tested positive” for the spores or toxin causing infant botulism.
However, California health officials previously identified the bacteria that causes botulism in an open can of formula fed to a baby who later developed the illness. The FDA has since conducted inspections at ByHeart manufacturing plants in Allerton, Iowa, and Portland, Oregon, though results from these inspections have not yet been released.
What Parents Need to Know
Infant botulism, while rare, can be devastating. It occurs when Clostridium botulinum spores germinate in an infant’s intestines, producing a toxin that causes paralysis and potentially death. The condition primarily affects babies under six months old, whose immature gut microbiota creates an environment where these spores can thrive.
What makes this outbreak particularly concerning? Symptoms can take up to 30 days to appear after exposure, meaning parents whose babies consumed the formula weeks ago still need to remain vigilant.
“While infant botulism is rare, it can progress quickly and requires prompt medical attention,” warned Dr. Hahn. Parents should watch for symptoms including constipation, poor feeding, weak cry, drooping eyelids, flat facial expression, weakness in limbs and head, a floppy feeling, and difficulty swallowing or breathing.
Federal and state health officials are urging parents and caregivers to immediately stop using any ByHeart formula products, including both cans and single-serve sticks. They recommend marking containers “DO NOT USE” but keeping them for at least a month in case symptoms develop and testing becomes necessary.
The California Department of Public Health, which operates the Infant Botulism Treatment and Prevention Program, has launched a public hotline at 833-398-2022, staffed daily from 7 a.m. to 11 p.m. PST. Officials report the hotline has already fielded hundreds of calls from concerned parents and caregivers.
Parents whose children consumed ByHeart formula should wash all items and surfaces that may have touched the product with hot, soapy water or in a dishwasher. If an infant shows any symptoms, medical attention should be sought immediately.
So far, all hospitalized infants have received treatment with BabyBIG®, a specialized medication for infant botulism. Though the situation remains serious, health officials note that no deaths have been reported in connection with the outbreak.
