Thirty-one infants in 15 states have been hospitalized with infant botulism after consuming ByHeart formula, with the latest case reported Nov. 13. Investigators in multiple states continue to find recalled cans on store shelves despite a nationwide recall and ongoing FDA inspections. Officials urge consumers to stop using any ByHeart product, mark it "DO NOT USE," retain it for possible testing, and call the California hotline at 833-398-2022 with concerns. No deaths have been reported.
31 Infants Hospitalized After ByHeart Formula; Recalled Cans Still Found on Store Shelves
Thirty-one infants in 15 states have been hospitalized with infant botulism after consuming ByHeart formula, with the latest case reported Nov. 13. Investigators in multiple states continue to find recalled cans on store shelves despite a nationwide recall and ongoing FDA inspections. Officials urge consumers to stop using any ByHeart product, mark it "DO NOT USE," retain it for possible testing, and call the California hotline at 833-398-2022 with concerns. No deaths have been reported.
05:33 AM, 11/20/2025Health
Health officials report that 31 infants across 15 states have been hospitalized and treated for infant botulism after consuming ByHeart infant formula. The most recent case was reported on Nov. 13. No deaths have been reported.
Investigators in at least three states discovered recalled ByHeart products still for sale about a week after the New York-based company issued a nationwide recall. In Oregon, inspectors checked more than 150 stores and found the formula available at nine locations. Minnesota investigators conducted 119 checks between Nov. 13 and Nov. 17 and removed recalled product from sale at four sites. Arizona officials also reported finding the product for sale.
The U.S. Food and Drug Administration has inspected ByHeart manufacturing facilities in Allerton, Iowa, and Portland, Oregon; results from those inspections have not yet been released. ByHeart said it voluntarily recalled all infant formula products "in close cooperation" with the FDA and stated that no unopened cans have tested positive for the spores or toxin that cause infant botulism. California officials, however, confirmed finding the bacteria associated with the illness in an opened can of ByHeart formula that had been fed to an infant who later developed botulism.
About infant botulism
Infant botulism occurs when bacterial spores germinate in an infant's intestines and produce a nerve‑paralyzing toxin. Symptoms can take up to 30 days to appear and commonly include constipation, poor feeding, a weak cry, drooping eyelids or a flat facial expression. Affected infants may become weak or "floppy," have trouble swallowing or breathing, and can develop limb and head weakness. Prompt medical attention is essential if any symptoms appear.
Retail and consumer guidance
ByHeart had been producing roughly 200,000 cans of formula per month; its products were sold online and at retailers including Target and Walmart. Walmart says it placed restrictions to prevent sale of the formula, removed available product from stores, and notified customers who purchased it. Customers may return cans for a refund. The formula retailed for about $42 per can.
Federal and state health officials warn that recalled ByHeart product may still be in homes. Officials advise stopping use of any ByHeart product — including cans and single‑serve sticks — and marking it clearly "DO NOT USE." Keep the product for at least a month in case a baby develops symptoms and the formula needs testing.
Help and reporting
California's health department operates the Infant Botulism Treatment and Prevention Program, which tracks cases and coordinates treatment. A public hotline has been established at 833-398-2022, staffed daily from 7 a.m. to 11 p.m. Pacific Time, to answer questions from parents and caregivers. Health officials also urge clinicians to report suspected infant botulism cases promptly so treatment can begin without delay.
If you believe an infant has been exposed to recalled formula or shows symptoms of botulism, contact your pediatrician or local health department immediately or call the hotline above.