Why a US distributor has recalled a generic drug made by an Indian pharma company

If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage since late October 2025 about an extensive recall of thousands of bottles of atorvastatin, the generic version of Lipitor.

Both generic atorvastatin and brand-name Lipitor contain the same active ingredient, atorvastatin calcium, and are considered bioequivalent by the US Food and Drug Administration. This medication is the number one-selling drug in the US, with over 115 million prescriptions going to more than 29 million Americans.

I am a clinical pharmacologist and pharmacist who has assessed the manufacturing quality of prescription, over-the-counter and illicit drugs, as well as dietary supplements.

This atorvastatin recall is large, potentially affecting hundreds of thousands of patients. But it’s only the latest in a series of concerning manufacturing issues that have come to light since 2019.

What pills are being recalled, and why?

Ascend Laboratories, based in New Jersey, originally issued the recall for about 142,000 bottles of its generic atorvastatin on September 19. Each bottle contained 90, 500 or 1,000 tablets, enough to fill prescriptions for three, 17 or 33 patients, respectively, for one month.

About three weeks later, on October 10, the FDA quantified the risk of using these poor-quality tablets and gave the recall a Class II status, which means that the medication could cause “temporary or medically reversible adverse health consequences”.

Manufacturers must conduct quality tests on random samples of tablets from every...

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