Overview
- Ascend Laboratories initiated a voluntary recall after testing showed some atorvastatin tablets failed dissolution specifications, which could reduce drug absorption and effectiveness.
- The FDA designated the action as a Class II recall, noting potential temporary or medically reversible adverse effects with a remote chance of serious harm.
- The tablets were manufactured by Alkem Laboratories in India and distributed nationwide by Ascend Laboratories in Parsippany, New Jersey.
- The action spans multiple strengths, including 10, 20, 40, and 80 mg, with specified lot numbers; affected 10 mg bottles include NDCs 67877-511-90, 67877-511-05, and 67877-511-10.
- Coverage this week underscored atorvastatin’s broad use in the U.S. and reported, without FDA confirmation, that impacted batches may date from November 2024 through September 2025.