More than 140,000 bottles of atorvastatin calcium tablets, a widely used cholesterol-lowering medication, have been recalled due to a defect that could reduce the drug’s effectiveness.
Ascend Laboratories, LLC, based in New Jersey, initiated the recall on September 19, 2025. In October, the recall was categorized as a Class II recall, meaning use of the product may cause temporary or medically reversible adverse health effects.
The tablets, manufactured by Alkem Laboratories, Ltd. in India and distributed by Ascend, failed a quality control test. Samples taken between November 2024 and September 2025 did not dissolve properly, which is necessary for the medication to be absorbed by the body. This defect could reduce the drug’s ability to lower cholesterol and increase the risk of cardiovascular problems.
The recall affects 10mg, 20mg, 40mg, and 80mg tablets of atorvastatin calcium.
How to Check Your Prescription
- Look at your prescription label for “MFG” or “MFR.”
- If it says “MFG Ascend” or “MFR Ascend,” your medication may be part of the recall.
- Patients are advised to contact their pharmacist to determine if their prescription is from one of the recalled lots and to arrange for a replacement if necessary.
What Patients Should Do
The Food and Drug Administration (FDA) advises patients not to stop taking the medication without consulting a healthcare provider.
Even if effectiveness is reduced, continuing the medication is considered safer than stopping it altogether until it is replaced.
Pharmacists can help verify whether your medication is affected and provide an alternative if needed.
