The ByHeart infant botulism outbreak case count has surged to 23 babies sick, according to the CDC, an increase of eight more illnesses since the last update was issued three days ago. One more state, Michigan, has been added to the investigation.
The case count by state is: Arizona (3), California (3), Illinois (2), Kentucky (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (2), Pennsylvania (1), Rhode Island (1), Texas (3), and Washington (1). For 22 infants whose age is available, they range in age from 16 to 200 days. Illness onset dates range from August 9 to November 11, 2025. All of the infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
Infant botulism is different from botulism in older children and adults. It begins when the baby swallows spores from the Clostridium botulinum bacteria. Those spores grow in the intestines and make the botulism toxin.
The California Department of Health had a presumptive positive test for Clostridium botulinum in an opened can of ByHeart Whole Nutrition Infant formula taken from the home of a sick baby. Other testing being conducted by the FDA and CDC is underway, but results take some time.
All of ByHeart’s formulas have been recalled. If you purchased any, stop feeding it to your infant immediately. You can throw the formula away in a secure trash can, or you can take it back to the store where you bought it for a full refund. Thoroughly clean and sanitize any containers, utensils, or bottles that came into contact with the powdered or reconstituted formula.
If you did feed your infant this product, monitor their health for the symptoms of infant botulism, which can take a few weeks to appear. If they do start exhibiting these symptoms, take them to the ER or your pediatrician immediately. They may be part of this ByHeart infant botulism outbreak.
If your infant has been sickened with a botulism food poisoning infection after being fed ByHeart infant formula, please contact our experienced attorneys for help with a possible lawsuit at 1-888-377-8900 or text us at 612-261-0856. Our Minnesota firm represents clients in lawsuits against grocery stores, restaurants, and food processors.
