Atorvastatin, which helps lower cholesterol and reduce risk of heart disease, is the No. 1-selling prescription drug in the US, according to ClinicCalc.

By Joe Lombardi From Daily Voice

A drug taken daily by millions of Americans has been recalled nationwide after federal regulators said it failed quality testing.

The recall affects more than 141,000 bottles of Atorvastatin Calcium Tablets, the most prescribed cholesterol-lowering medication in the US, according to a report from the Federal Drug Administration (FDA).

The tablets — sold under the Ascend Laboratories label — did not meet dissolution specifications, a measure that determines whether the drug properly breaks down in the body. The recall was initiated by Ascend Laboratories, LLC, based in Bedminster, New Jersey, and remains ongoing.

According to the FDA, multiple dosages of Atorvastatin Calcium Tablets were affected, including 10 mg, 20 mg, 40 mg, and 80 mg bottles distributed nationwide. The products were manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC, headquartered in Parsippany, New Jersey.

The voluntary recall was initiated on Friday, Sept. 19, 2025, and classified as Class II by the FDA on Friday, Oct. 10, 2025. Class II recalls are issued when use of a product could cause temporary or medically reversible health consequences.

A total of 141,984 bottles were included in the recall, according to FDA records.

No injuries or adverse reactions have been reported. The company notified distributors by letter and is arranging for product return and replacement.

Atorvastatin, which helps lower cholesterol and reduce risk of heart disease, is the No. 1-selling prescription drug in the US, according to ClinicCalc.

The FDA’s full recall listing is available here.

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