The ByHeart formula infant botulism outbreak has ended with 48 sick, according to the CDC. This outbreak case count has been confusing from the beginning. In the last update issued on December 11, 2025, there were allegedly 51 babies sick. And the FDA update lists 28 sick.
But the FDA numbers include 28 cases of confirmed botulism, 20 cases of probable botulism, and three cases of infants who were eventually diagnosed with another illness. The CDC counts all illnesses except those diagnosed with something else. The last update also included 19 states, but the state count hs been reduced t0 17. One thing remains true: all ByHeart infant formulas were recalled as a result of this outbreak.
The final case count by state is: Arizona (5), California (12), Idaho (2), Illinois (2), Kentucky (1), Massachusetts (2), Michigan (1), Minnesota (3), North Carolina (2), New Jersey (1), Ohio (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1). (This adds up to 50, furthering the confusion.) The infants range in age from 16 to 264 days. Illness onset dates range from December 24, 2023 to November 29, 2025. All of the infants were treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
The confirmed cases were infants who consumed ByHeart Whole Nutrition Infant formula, illnesses that started on or after March 23, 2022, and lab tests positive for C. botulinum bacteria or botulism toxin. Probable cases included infants with illnesses that started on or after March 23, 2022, negative or inconclusive lab results, but signs, symptoms, and recovery compatible with infant botulism and no alternative diagnosis. Infants that were removed from the outbreak consumed the formula, had illnesses that started on or after March 23, 2022, were negative la results, and with an alternate diagnosis from their healthcare provider.
The source of the contamination in the formula was the whole milk powder used to make it, according to ByHeart. The FDA’s investigation is still ongoing. The California Department of Public Health confirmed the presence of C. botulinum type A in a culture from an opened can of ByHeart formula that was fed to a sick infant.
If you have any of this formula in your house, do not use it. You can throw it away or take it back to the place of purchase. Do not donate or sell this formula.
If you fed your child this formula and he or she has been sick with the symptoms of infant botulism, take them to your doctor immediately. They may be part of this ByHeart Formula infant botulism outbreak.
If your infant has been sickened with an infant botulism 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.
