U.S. Senator Bill Cassidy, chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, has requested answers from ByHeart following reports that its infant formula was linked to 51 cases of infant botulism across 19 states.
In a letter addressed to ByHeart leadership, Cassidy stated: “Ensuring that parents and their infants have access to safe formula is essential for us to protect our most vulnerable population. There should never be any question about the quality of these products. The ongoing safety recall affecting ByHeart products undermines access to safe, quality infant formula by putting pressure on the overall supply of infant formula.”
Cassidy’s concerns follow a voluntary recall recommended by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on November 8 after an outbreak of infant botulism among infants who consumed ByHeart powdered formula. Federal agencies are continuing their investigation into the outbreak.
The senator cited inspection reports indicating safety deficiencies at ByHeart facilities, including failures in contamination prevention measures. He emphasized the need for public understanding of how infants were infected and called for steps to strengthen protections around infant formula safety.
Cassidy’s letter included specific questions for ByHeart regarding when it became aware of safety concerns, its engagement with retailers and regulators, details about safety processes in place, third-party oversight involvement, facility inspections, and previous identification or resolution of hazards at company locations in Allerton, Iowa; Portland, Oregon; or Reading, Pennsylvania.
He also referenced FDA inspection records from 2022 through March 2025 that noted non-compliance with good manufacturing practices (GMPs), such as not maintaining sanitary conditions in production facilities. Cassidy asked for detailed information about GMP deficiencies identified during this period and how they were resolved.
Other queries covered whether ByHeart had removed any batches sold abroad or engaged with foreign product regulators on safety issues.
The Senate Health, Education, Labor, and Pensions Committee is responsible for legislating on public health matters and oversees federal agencies like the FDA (official website). In the current Congress, Bill Cassidy serves as chair (official website). The committee influences regulations impacting health across the United States (official website) and provides oversight over relevant federal laws and agencies (official website).
For updates from HELP Republicans visit their website or Twitter @GOPHELP.
