As of last update in December 2023, the FDA addressed "Reformulating Drug Products That Contain Carbomers Manufactured with Benzene".
Benzene, a known human carcinogen, can inadvertently contaminate drug products during manufacturing processes involving carbomers. Carbomers are commonly used in pharmaceutical formulations as thickening agents, gelling agents, and stabilizers.
In response to concerns about benzene contamination, the FDA continuously monitors drug safety and provides guidance to the pharmaceutical industry. This guidance may include recommendations for reformulating drug products to mitigate benzene contamination risks and ensure compliance with safety standards.