Baby Formula Woes: Parents Seek Answers on Early Botulism Cases

Parents are raising concerns about potential early cases of infant botulism linked to ByHeart baby formula. While health officials are currently investigating over 30 cases since August, some families claim their babies fell ill much earlier, possibly as far back as November 2024. California health officials have confirmed that six infants in the state were treated for botulism between November 2024 and June 2025 after consuming ByHeart formula. However, officials stated that there wasn't enough evidence at the time to suspect a common source. Even now, they say they can't connect these earlier cases to the current outbreak. Amy Mazziotti from Burbank, California, shared that her 5-month-old son, Hank, became ill and was treated for botulism in March after starting to drink ByHeart formula. Similarly, Katie Connolly from Lafayette, California, said her 8-month-old daughter, M. C. , was hospitalized and treated for botulism in April after being fed ByHeart formula. For months, these mothers had no idea where the infections came from. Typically, infant botulism is caused by spores found in the environment or contaminated honey. It wasn't until ByHeart recalled all its products nationwide on November 11 that the connection became apparent. ByHeart officials confirmed that laboratory tests on unopened formula samples found some were contaminated with bacteria that cause infant botulism. Bill Marler, a Seattle food safety lawyer representing the families, said at least three other cases predating the outbreak involved babies who drank ByHeart and were treated for botulism. Dr. Jennifer Cope, a CDC scientist leading the investigation, acknowledged that federal investigators are aware of reports of earlier illnesses. However, their focus is currently on understanding the surge of infections documented since August. She noted that linking earlier cases to the outbreak is challenging due to the time that has passed and the lack of recorded lot numbers or kept formula cans. Parents like Connolly and Mazziotti are left with lingering questions and a sense of being forgotten. They want to know why the cases beginning in August triggered an investigation, but the earlier cases did not. Health officials explained that the strong signal connecting ByHeart to infant botulism cases only became apparent in recent weeks. Before this outbreak, no powdered infant formula in the U. S. had tested positive for the type of bacteria that leads to botulism. The number of cases was within the expected range, and a test of an open formula can fed to a sick baby in the spring did not detect the bacterium. However, starting in August, more cases were identified on the East Coast, involving a type of toxin rarely detected in the region. Earlier this month, after a sample from a can of ByHeart formula fed to a sick infant tested positive for the germ that leads to illness, officials notified the CDC, the FDA, and the public. Less than 200 cases of infant botulism are reported in the U. S. each year, and the bacterium that causes the illness is ubiquitous in the environment, including soil and water. Outside food safety experts argue that the CDC should count earlier cases as part of the outbreak if babies consumed ByHeart formula and were treated for botulism. Frank Yiannas, former deputy commissioner for food policy and response at the FDA, and Sandra Eskin, chief executive of STOP Foodborne Illness, both agreed that these cases should be included. Connolly and Mazziotti said their babies are improving, though they still have some lingering effects. Botulism causes symptoms that include constipation, poor feeding, head and limb weakness, and other problems. After months of uncertainty, Connolly said she became completely obsessed with the link to ByHeart formula and now wants answers.