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FDA Recalls 140k Bottles of Generic Lipitor

by | Oct 30, 2025 | Product Liability

More than 140,000 bottles of a commonly prescribed statin have been recalled due to “failed dissolution specifications,” according to the U.S. Food and Drug Administration.

The New Jersey-based Ascend Laboratories recalled Atorvastatin Calcium, a statin drug sold as a generic form of Lipitor because the drug failed to dissolve properly according to federal standards.

The recalled drug was manufactured by Alkem Laboratories of India and distributed nationwide.

Here’s what you need to know about which tablets are part of the recall and what you should do if you have the recalled medication.

Which Atorvastatin calcium tablets are part of the recall?

The recall was first initiated on Sept. 19, and covers tablets bottled in 90-count, 500-count and 1,000-count quantities with expiration dates as far out as Feb. 2027.

According to the FDA, the tablets were classified as a Class II recall on Oct. 10, meaning that the “product may cause temporary or medically reversible adverse health consequences.”

If you or a loved one suffered losses due to ingesting this medication, you may be entitled to compensation. To learn more, contact the trusted product liability attorneys at Breslin and Breslin today.

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