Over 140,000 Bottles of Cholesterol Drug Recalled After Failing Dissolution Tests, FDA Warns

By

FDA Suspends Milk Testing Program Due to Mass Employee Departures
sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Sarah Silbiger/Getty Images/Getty Images

Federal health officials are warning consumers that more than 140,000 bottles of a popular cholesterol-lowering medication have been recalled due to "failed dissolution specifications."

The US Food and Drug Administration (FDA) said the recall affects several bottle sizes of Atorvastatin Calcium Tablets, 10-mg, a prescription drug used to lower cholesterol and reduce the risk of heart disease, heart attacks, and strokes.

Atorvastatin, the generic form of Lipitor, belongs to a group of drugs called statins.

These medications work by blocking an enzyme in the liver that produces cholesterol.

When a pill fails dissolution testing, it means the medication does not dissolve as it should in laboratory conditions. This could make the drug less effective at controlling cholesterol levels.

According to the NY Post, the recall, issued on Sept. 19, covers bottles containing 90, 500, and 1,000 tablets with expiration dates ranging from July 2026 to February 2027.

The affected medications were manufactured by Alkem Laboratories in India and distributed across the US by Ascend Laboratories LLC of New Jersey.

On Oct. 10, the FDA classified the recall as a Class II event. This means the use of the recalled product "may cause temporary or medically reversible adverse health consequences," but serious health issues are considered unlikely.

FDA: Check Atorvastatin Bottles

Dr. Tamanna Singh of the Cleveland Clinic highlighted the importance of statins, saying "about 39 million adult Americans" use them to manage cholesterol, with most users over the age of 40.

She noted that Lipitor, Crestor, and their generic versions remain the most prescribed statins.

Consumers are being advised to check their Atorvastatin bottles for the lot numbers listed in the recent recall and to reach out to their pharmacy or healthcare provider if they're unsure.

Although neither the FDA nor Ascend Laboratories has released detailed steps on what to do with the recalled tablets, sources like GoodRx suggest verifying the lot number, consulting a pharmacist, and safely disposing of any affected medication.

The recall includes several Atorvastatin strengths and bottle sizes. For instance, 10 mg tablets are tied to lots expiring between July 2026 and February 2027, while 20 mg, 40 mg, and 80 mg versions fall within a similar range, USA Today reported.

A complete list of affected lots can be found in the FDA's enforcement report.

Patients currently taking Atorvastatin shouldn't stop their medication on their own but should first confirm with a healthcare provider whether their prescription is part of the recall.

© 2025 VCPOST.com All rights reserved. Do not reproduce without permission.

Join the Conversation