More than 140,000 bottles of a popular prescription medication used to treat high cholesterol have been recalled because of a flaw that may limit the effectiveness of the drug. Ascend Laboratories, the company that distributes the medication, first recalled its atorvastatin calcium tablets on Sept. 19, but last month changed the recall to a “Class II” status, which means health officials suspect that use of the medication could lead to temporary or reversible side effects.
Atorvastatin is the generic form of Lipitor. It is reportedly the most-prescribed drug in the United States and is meant to reduce bad cholesterol, decreasing the risk of a heart attack.
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The reported defect
The recalled pills failed to pass a quality control test, according to Ascend Laboratories. The samples of the medication, which were taken between November 2024 and September 2025, did not dissolve as intended. That’s a problem, as medical professionals say the pill must dissolve properly in order for the active ingredients to be absorbed by the body and work effectively. That also means an increased risk of heart problems.
“So, while patients wouldn’t immediately feel a difference if their atorvastatin tablets didn’t dissolve properly, their risk of cardiovascular events would significantly rise,” Dr. C. Michael White, who works at the Department of Pharmacy Practice at UConn, explains in an article for The Conversation.
The impacted drugs include bottles of 10 mg, 20 mg, 40 mg and 80 mg of the atorvastatin calcium tablets made by India-based Alkem Laboratories and distributed by Ascend.
What to look for
White urges people to examine their prescription labels for the following abbreviations. He said MFG stands for “manufacturing” or MFR for “manufacturer.” White said a label that reads: “MFG Ascend” may potentially indicate the medication is part of the company’s recalled batches.
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Atorvastatin is the top selling drug in the United States with more than 115 million reported prescriptions for more than 29 million Americans.
Advice for those with impacted bottles
He added that if a patient discovers these labels on the bottle, they should call a pharmacist to determine if the pills are part of the recalled batch. If recalled, a patient can have their pills swapped out for a different medication that isn’t under recall, according to White.
Unlike other recalls, the Food and Drug Administration (FDA) does not want people to throw the medication out if it’s an affected prescription.
“In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine,” the FDA states.
The agency stated that even if the effectiveness of the medication is impacted, taking the prescribed medication is better than not taking anything at all, and also reiterated that a pharmacist can assist patients with replacements for their medication.