Federal health officials have announced a large-scale recall of more than 140,000 bottles of a widely used cholesterol medication after the drug failed to meet quality standards during testing. According to the U.S. Food and Drug Administration (FDA), several bottle sizes of Atorvastatin Calcium Tablets (10 mg), the generic form of Lipitor, are being recalled due to “failed dissolution specifications.”
This means the medication did not dissolve properly in laboratory testing, which could make it less effective at controlling cholesterol levels. Atorvastatin Calcium Tablets are prescribed to lower cholesterol and reduce the risk of heart disease, heart attacks, and strokes. The medication works by blocking an enzyme in the liver responsible for producing cholesterol.
The FDA stated that the affected tablets were manufactured by Alkem Laboratories and distributed by Ascend Laboratories LLC. The recall involves multiple bottle sizes, including 90-count, 500-count, and 1,000-count containers, with expiration dates ranging from July 2026 to February 2027. Eight specific lot numbers have been identified in the recall notice.
The agency classified the recall as a Class II recall, which is issued when a product’s use “may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.” While not considered immediately life-threatening, the FDA warns that patients may not receive the intended therapeutic benefits if the medication fails to dissolve and absorb as expected.
“Failed dissolution specifications” indicate that the tablets may not deliver the proper amount of medication into a patient’s bloodstream, potentially leaving cholesterol levels uncontrolled and increasing cardiovascular risks for some patients. The FDA’s enforcement report did not indicate any known injuries or adverse events associated with the recalled medication so far.
However, health experts recommend that patients who use Atorvastatin check the packaging of their prescriptions to see if their lot number matches any of the recalled batches. Patients are advised not to stop taking the medication without consulting their healthcare provider, as doing so abruptly could increase the risk of heart-related complications.
Pharmacies and distributors are being instructed to remove affected products from circulation while the investigation continues. Consumers can visit the FDA’s website for the full recall list and further instructions on how to identify affected products.