Over 140,000 bottles of a prescription statin have been pulled from the market due to “failed dissolution specifications,” according to a report by the U.S. Food and Drug Administration (FDA). Ascend Laboratories, based in New Jersey, recalled Atorvastatin Calcium, a generic version of Lipitor, manufactured by Alkem Laboratories of India and distributed across the country. The recall covers tablets in 90-count, 500-count, and 1,000-count bottles with expiration dates extending to February 2027.Atorvastatin Recall: Why Is The Popular Cholesterol Medicine Being Recalled?On October 10, 2025, the FDA classified the recalled drug as a Class II recall. This classification means the medication could cause “temporary or medically reversible adverse health effects,” though the likelihood of serious harm is considered “remote.”Statins are widely prescribed to manage high cholesterol and to prevent or reduce heart disease, according to a 2023 study from Florida Agricultural and Mechanical University.Dr. Tamanna Singh of the Cleveland Clinic noted on a September podcast that roughly “39 million adult Americans” take statins, with the largest group being over 40. She added that Lipitor, Crestor, and their generics, atorvastatin and rosuvastatin, are the most commonly prescribed medications in this class.Atorvastatin Recall: Why This Cholesterol-Lowering Drug Recall MattersMost drug recalls are initiated by the manufacturers themselves, and this appears to be the case here. The recalled product is made by New Jersey-based Biocon Pharma, Inc. “Recalls are typically initiated voluntarily by companies before they notify the FDA,” explained Dr. Ileana Elder, Branch Chief in the Incidents, Recalls, and Shortages Branch at the FDA’s Center for Drug Evaluation and Research, in a 2024 Q&A.Atorvastatin Recall: What Should People Do With the Recalled Medication?Neither the FDA nor the companies have issued detailed instructions on handling the recalled tablets. GoodRx advises anyone affected by a recall to check their medication’s lot number, contact their pharmacy, reach out to their prescriber, and properly dispose of the recalled medication.Statins like atorvastatin are among the most commonly prescribed drugs for lowering “bad” cholesterol and reducing heart disease risk, meaning many adults could be affected. A failure in dissolution means the medication may not deliver the correct dose, which can compromise treatment effectiveness, particularly for those relying on consistent cholesterol control.The recall being classified as Class II (risk of temporary or reversible harm) highlights that the risk is serious but not immediately life-threatening. Because generic medications are widely used and often more affordable, many patients may not realise their specific bottle is impacted and may continue taking it, assuming it is safe.Atorvastatin Recall: How to Check if Your Bottle Is AffectedCheck your prescription bottles for the manufacturer, lot number, and bottle size listed in the FDA notice.If your medication is part of the recall, do not stop taking it suddenly—contact your healthcare provider for guidance and request a replacement or alternate formulation. Keep any affected bottles separate, and avoid sharing your medication, as only specific batches have been flagged. Always store your medications correctly, and check with your pharmacy at each refill to ensure the lot and manufacturer are free of recalls.
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