The number 5 outbreak of 2025 is the Byheart infant formula botulism outbreak that is still ongoing. There are at least 51 infants in 19 states who have been sickened in this outbreak; all have been hospitalized.
The case count by state is: Arizona (5), California (12), Idaho (2), Illinois (2), Kentucky (1), Massachusetts (2), Maine (1), Michigan (1) Minnesota (3), North Carolina (2), New Jersey (1), Ohio (1), Oregon (4), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1). The infants range in age from 16 to 264 days. Illness onset dates range from December 24, 2023 to December 1, 2025. All of the infants were treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
The FDA determined that they couldn’t say with certainty that contamination was limited to the originally recalled products, so the case definition was expanded to include any infant with botulism who was fed ByHeart formula at any time since the products were first released in March 2022. All of ByHeart’s products were recalled.
One other disturbing fact in this investigation: the formula was found on store shelves after the first recall was issued. It is illegal to sell or donate any food that has been recalled by the USDA or FDA.
If you have any ByHeart formula, do not feed it to your child. You can throw it away in a secure garbage can with a tight fitting lid, after first wrapping or double bagging the product so other people can’t see it, or you can take it back to the store where you purchased it for a full refund.
If you fed your child ByHeart formula recently, monitor their health for the symptoms of infant botulism for a few weeks. Symptoms are different from adult symptoms. If they do start showing signs of this infection, take them to your pediatrician or an emergency room immediately and tell them they were fed the formula.
If your child has been sickened with a food poisoning infection, please contact our experienced attorneys for help with a possible lawsuit at 1-888-377-8900 or text us at 612-261-0856. Our firm represents clients in lawsuits against grocery stores, restaurants, and food processors.
