More than 140,000 bottles of a widely prescribed cholesterol medication have been recalled across the United States. The affected drug, Atorvastatin Calcium tablets—a generic form of Lipitor—was pulled after testing showed it failed to meet key quality standards set by the U.S. Food and Drug Administration (FDA).
The recall, issued by Ascend Laboratories, LLC, involves multiple strengths and packaging sizes of the medication used to lower cholesterol and reduce the risk of heart disease and stroke. Here’s what to know about the recall, which products are affected, and what to do if you have one of these bottles at home.
Cholesterol drug recall: what happened
According to the FDA, the recall affects at least 141,984 bottles of Atorvastatin Calcium tablets manufactured by Alkem Laboratories, Ltd. in India and distributed nationwide by Ascend Laboratories, based in New Jersey. The agency cited “failed dissolution specifications”—meaning the medication may not break down properly in the body—as the reason for the recall.
Atorvastatin is one of the most commonly prescribed statins in the U.S., used by millions of Americans to help lower LDL (“bad”) cholesterol levels and prevent heart-related conditions such as coronary artery disease and stroke. It works by reducing cholesterol production in the liver, helping to clear excess cholesterol from the bloodstream.
The recall covers multiple dosages—including 10 mg, 20 mg, 40 mg, and 80 mg tablets—sold in 90-count, 500-count, and 1000-count bottles. Affected lots have expiration dates between June 2026 and February 2027. These details can be found on the medication label or packaging, allowing consumers to check whether their prescription is included.
While the recall is considered a Class II recall, which indicates a possibility of temporary or medically reversible health effects, patients are still advised to act with caution. There’s no evidence of immediate danger or reports of serious injury, but medications that don’t dissolve as intended may not provide the expected therapeutic benefit.
The FDA’s recall announcement comes amid growing scrutiny over the quality of generic drugs produced abroad and distributed in the U.S. In this case, the issue was identified through quality testing, not patient complaints or adverse events.
What to do if you have the recalled medication
If you’re currently taking Atorvastatin Calcium tablets, check your prescription bottle for the lot number and expiration date. If it matches one of the recalled batches, contact your pharmacy or healthcare provider right away. They can confirm whether your medication is affected and arrange for a replacement or refund.
The FDA recommends not stopping your medication without consulting your doctor first. Abruptly discontinuing statins can raise cholesterol levels and increase the risk of heart attack or stroke, especially for people with existing cardiovascular conditions.
For more information, consumers can contact the FDA’s Division of Drug Information at 1-888-INFO-FDA (1-888-463-6332) or visit the FDA’s official recall database. Pharmacies that sold the affected product should also provide details on refund or return procedures.
Atorvastatin remains an effective and trusted medication for managing cholesterol when manufactured and stored properly. This recall affects only specific lots distributed by Ascend Laboratories. If you’re unsure whether your medication is safe, take the bottle with you to your next pharmacy visit or doctor’s appointment. It’s better to double-check than to risk taking a product that isn’t performing as it should.