Rep. Rosa DeLauro (D-CT) is demanding to see the ByHeart inspection records after the outbreak of infant botulism linked to that company’s products has sickened at least 23 infants in 13 states. All of the infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
The case count by state is: Arizona (3), California (3), Illinois (2), Kentucky (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (2), Pennsylvania (1), Rhode Island (1), Texas (3), and Washington (1). For 22 infants whose age is available, they range in age from 16 to 200 days. Illness onset dates range from August 9 to November 11, 2025. All of ByHeart’s products have been recalled.
Rep. DeLauro said in a statement, “There must never be a question in parents’ minds that the formula they give to their children is safe. The New York Times’ reporting about a botulism outbreak linked to ByHeart’s formula, along with alarming details of safety and hygiene violations at a separate ByHeart facility, is deeply alarming and I am requesting all available information about this company’s practices.
“FDA plays a vital role in protecting our nation’s food supply, yet once again these safety violations were revealed to the nation by reporters, not our public watchdog. As the Chair of the Food Safety Caucus, I will continue to press FDA for answers and transparency about its investigation practices. There is no excuse for inaction when children’s safety is on the line.”
The letter states, “According to the New York Times, ByHeart shut down one of its manufacturing plants earlier this year after federal investigators found a series of safety violations, including a leaking roof and hundreds of dead bugs where infant formula was produced. Inspectors found more than 2,700 dead insects in a food production area. The FDA classified the inspection as its highest tier of concern. This reporting raises serious concerns about the company’s food safety record.”
She requested that the information about inspections be sent to her by Wednesday, November 19, 2025.
