Parents of infants who fell ill with botulism months before the recent outbreak linked to ByHeart baby formula are demanding answers. California health officials confirmed that six babies who consumed ByHeart formula were treated for botulism between November 2024 and June 2025, up to nine months before the outbreak affecting at least 31 babies in 15 states. Initially, there was insufficient evidence to suspect a common source. Even now, officials cannot definitively connect pre-August 1 cases to the current outbreak. Parents of at least five babies reported their infants were treated for botulism after consuming ByHeart formula in late 2024 and early 2025. Amy Mazziotti's 5-month-old son, Hank, and Katie Connolly's 8-month-old daughter, M.C., were both hospitalized and treated for botulism after being fed ByHeart formula. The mothers had no prior knowledge of the potential source of the infections, which are typically caused by environmental spores or contaminated honey. ByHeart recalled all its products nationwide on November 11 in response to the growing number of infant botulism cases. Laboratory tests confirmed that previously unopened formula samples were contaminated with the bacteria that causes infant botulism. Bill Marler, a Seattle food safety lawyer, shared reports of at least three other cases predating the outbreak, involving babies who drank ByHeart and were treated for botulism. The U.S. Centers for Disease Control and Prevention acknowledges reports of earlier illnesses but is currently focused on the surge of documented infections since August 1. Time has passed, making it challenging to definitively link earlier cases to the outbreak due to potential lack of product lot number records. Connolly feels her daughter has been forgotten, questioning why cases beginning in August prompted an investigation, while those in March did not. Health officials emphasize that the connection between ByHeart and infant botulism cases became apparent only in recent weeks. Before the outbreak, no powdered infant formula in the U.S. tested positive for the botulism-causing bacteria, and the number of cases was within the expected range. The outbreak was identified on the East Coast in August, involving a rare toxin type, with a higher incidence in very young infants and ByHeart formula, which accounts for less than 1% of infant formula sales. The AP Health and Science Department, supported by the Howard Hughes Medical Institute and the Robert Wood Johnson Foundation, is solely responsible for the content.
