Overview
- The FDA classified the action as a Class II recall on Oct. 10, indicating possible temporary or reversible effects with a remote chance of serious harm.
- Ascend initiated the voluntary recall on Sept. 19 after testing found some tablets failed to dissolve as required, potentially reducing effectiveness.
- Affected lots include 10 mg, 20 mg, 40 mg and 80 mg tablets in 90-, 500- and 1,000-count bottles with expiration dates through February 2027.
- The tablets were manufactured by Alkem Laboratories in India and distributed nationwide by New Jersey-based Ascend Laboratories.
- No illnesses have been reported, and consumers are advised to check lot numbers and consult their pharmacy or prescriber for guidance.