More Than 140,000 Bottles of Cholesterol Medication Recalled Nationwide

The nationwide recall covers atorvastatin calcium tablets in 10-, 20-, 40-, and 80-milligram doses.

Published: 10/17/2025, 12:48:25 PM EDT

More Than 140,000 Bottles of Cholesterol Medication Recalled Nationwide — Atorvastatin calcium, a drug used to lower cholesterol in the blood, in a stock photo. (Shutterstock)

More than 140,000 bottles of a widely prescribed cholesterol-lowering medication are being recalled nationwide. Federal regulators said the pills failed to meet dissolution standards—potentially making them less effective than intended.

The Food and Drug Administration (FDA) announced that multiple lots of generic atorvastatin calcium tablets—a drug commonly used to treat high cholesterol and prevent heart disease—were voluntarily recalled by Ascend Laboratories LLC of Bedminster, New Jersey.

The tablets were manufactured by Alkem Laboratories Ltd. in India, according to an FDA recall notice dated Oct. 10.

The FDA classified the action as a Class II recall, meaning “a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

According to the FDA, several batches of the drug “failed dissolution specifications.” This means that the tablets did not dissolve at the expected rate under federal guidelines. Improper dissolution could prevent patients from properly absorbing the active ingredient and reduce the drug’s effectiveness.

The nationwide recall covers atorvastatin calcium tablets in 10-, 20-, 40-, and 80-milligram doses. According to FDA data, 10-milligram tablets were packaged in 90-, 500-, and 1,000-count bottles—amounting to 141,984 bottles included in the recall. Larger-count bottles of the higher-dose tablets were also affected.

The agency said the recall was initiated Sept. 19 and remains ongoing.

The American Association of Retired Persons (AARP) advises that consumers notified of a prescription drug recall should contact their doctor or pharmacist before making any changes.

Atorvastatin is part of the statin drug class, which works by reducing cholesterol production in the liver. It ranks among the most commonly prescribed medications in the United States. "Statins are usually the first drug used to treat people with high cholesterol levels (high LDL) or heart disease," according to Drugs.com.

The recall covers multiple lots with expiration dates ranging from July 2026 to February 2027, the FDA said. Affected lot numbers include 25141249, 24144938, 24144868, 24144458, 24143994, 24142987, and 24143316, among others. Each lot number recalled can be found on the FDA's recall notice. The recall event ID number is 97639.

A 2024 FDA inspection of Alkem Laboratories in Baddi uncovered several "inspectional observations" that highlighted significant deficiencies in the company's quality control systems.

Among the findings, the agency noted failures “to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications,” even after the batch had already been distributed.

One notable example cited in the report involved a UV spectrophotometer that malfunctioned in June 2023. Alkem did not investigate whether this equipment failure had affected previous test results; as a result, batches tested with the faulty instrument were still released to the U.S. market.