(NEXSTAR) – A recall has been issued for over 141,000 bottles of a cholesterol-lowering medication due to “failed dissolution specifications,” indicating that the drug didn’t pass a solubility test.
Ascend Laboratories LLC, a pharmaceutical company located in New Jersey, announced the recall of atorvastatin calcium tablets on September 19, 2025, as reported by the U.S. Food and Drug Administration.
The recalled products have been classified as a “Class II” recall, which, according to the FDA, means that using the recalled item “could cause temporary or medically reversible health harm or is unlikely to cause serious health harm.”
This recall specifically impacts atorvastatin calcium tablets in 10 mg, 20 mg, 40 mg, and 80 mg dosages, produced by Alkem Laboratories, Ltd. in India and distributed by Ascend. Nearly 142,000 bottles of the 10 mg tablets are included, with other dosage counts also mentioned in the FDA’s enforcement report.
More detailed information about the specific recalled products, including lot numbers and expiration dates, can be found in the FDA’s report.
Representatives from Ascend Laboratories LLC were not immediately available for comment, and the company has yet to provide guidance to consumers who have these recalled medications. The FDA advises individuals to consult their healthcare providers, but also notes, “Consumers can generally continue taking their medications unless the recall company instructs otherwise.”
In some situations, discontinuing the medication might pose a greater health risk than continuing to take a recalled drug, according to the FDA.
Atorvastatin calcium is primarily used to manage cholesterol levels and is known to help in preventing heart attacks and strokes. Its most common brand name is Lipitor, made by Pfizer. Estimates suggest that over 40 million Americans are prescribed statins, making them the most widely prescribed medications in the country.
