Overview
- Ascend Laboratories initiated the recall on Sept. 19, and the FDA designated it Class II on Oct. 10 for tablets linked to medically reversible risks.
- Quality testing found tablets failed dissolution specifications across batches made from November 2024 through September 2025, reducing absorption and effectiveness.
- The recalled product is distributed in the U.S. by Ascend but manufactured by Alkem Laboratories in India, and no illnesses have been reported.
- Patients should check prescription labels for Ascend or NDC starting with 67877, consult pharmacists before switching, and continue statin therapy unless advised otherwise.
- The recall reflects ongoing manufacturing lapses and spurs expanded FDA spot testing and EMA collaboration, following issues such as Alkem’s 2023 metoprolol XL recall and Glenmark’s 2024 potassium chloride recall.