A single lot of acamprosate calcium delayed-release tablets has been recalled after failing dissolution testing, meaning the tablets may not release the active drug the way they are supposed to. The medication is prescribed to help people with alcohol use disorder stay abstinent after they have already stopped drinking.
The recall covers one lot of the 333 mg tablets in 180-count bottles, with an October 2026 expiration date. Mylan initiated the action, which appears in the agency's weekly enforcement listings according to enforcement report tracking. MedicalDaily is not publishing a lot number because the specific code could not be confirmed against a primary FDA record, and printing the wrong one would give patients false reassurance.
