The ByHeart Infant Formula botulism outbreak has now sickened 15 babies in 12 states, according to the Centers for Disease Control and Prevention (CDC). That is an increase of two more patients in two more states since the last update was issued three days ago. The new states are Kentucky and New Jersey.
The case count by state is: Arizona (1), California (2), Illinois (2), Kentucky (1), Minnesota (1), North Carolina (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). For 14 infants whose age is available, they range in age from 16 to 157 days. Illness onset dates range from August 9 to November 10, 2025. All of the infants were hospitalized and treated with BabyBIG®. No deaths have been reported.
According to information from the Infant Botulism Treatment and Prevention Program (IBTPP), 84 infants in the United States have received BabyBIG® treatment in the U.S. since August 2025. Among them, 36, or 43%, had powdered infant formula exposure. More than 40% of that group consumed ByHeart Whole Nutrition Infant formula. This formula is disproportionately represented among sick infants, especially since ByHeart comprises only about 1% of all infant formula sales in this country. The FDA is investigating, but no other infant formula brands or shared exposures have been identified.
Preliminary laboratory reports conducted by the California Department of Public Health suggest the presence of Clostridium botulinum in an open can of ByHeart formula with lot number 206VABP/251131P2. Additional testing by the FDA and CDC is ongoing; results will take a few weeks.
All ByHeart infant formula has now been recalled. Parents and caregivers are urged to stop using all ByHeart infant formulas, including those that were not included in the original recall. You can throw it away or take it back to the place of purchase for a refund. Clean any containers or utensils that may have come into contact with the formula.
If you fed your child ByHeart formula, monitor their health closely for the symptoms of infant botulism, which can take several weeks to appear. If they do appear sick, see your doctor immediately. They may be part of this ByHeart infant formula botulism outbreak.
If your child has been sickened with a botulism food poisoning infection after feeding 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.
