Cholesterol Medication Recall Affects More Than 13,000 Bottles Over Odd Safety Issue

The tablets involved are a generic version of a widely used statin.

For about 47 million Americans, managing high cholesterol with medication is part of everyday life. Statins are among the most commonly prescribed cholesterol drugs, and they lower the body’s production of “bad” cholesterol, according to the Cleveland Clinic.

Most people do not give much thought to the pills in their prescription bottles, but a nationwide recall is prompting a closer look.

Why the recall was issued

An FDA enforcement report released in late October disclosed a Class II recall of prescription atorvastatin calcium tablets, the generic form of Lipitor, because of the “Presence of Foreign Tablets/Capsules.” The agency did not identify what those foreign tablets or capsules were.

A Class II recall indicates the medication could cause temporary health problems, though FDA experts concluded the chance of a serious health issue is remote. The product was manufactured by India-based MSL Laboratories Private Limited and distributed across the country by Novadoz Pharmaceuticals.

The recall covers 13,296 bottles, with each bottle containing 1,000 tablets. That volume suggests the bottles were likely intended for pharmacies to dispense into individual prescriptions.

How to tell whether your medication is included

The recalled product is prescription-only and can be identified by these details:

Atorvastatin Calcium Tablets, USP, 40 mg

• NDC: 72205-024-99
• Lot numbers and expiration dates:
  • DRF09618A; 8/31/2029
  • DRG02110A; 1/31/2030

If you take atorvastatin and think your medicine may be affected, contact your pharmacist to confirm whether your prescription came from one of the recalled lots.