More than 6,000 bottles of a prescription blood pressure medication have been recalled nationwide after testing found one of its active ingredients did not meet quality standards, raising concerns that some patients may not receive the drug’s intended effect.
Ascend Laboratories LLC recalled 6,192 bottles of Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, after stability testing showed the olmesartan medoxomil component failed dissolution testing. Dissolution measures how well a medication breaks down in the body. If it dissolves too slowly, the medicine’s effect may be delayed or reduced.
The U.S. Food and Drug Administration (FDA) classified the recall as Class II on July 20. A Class II recall means use of the product could cause temporary or medically reversible health effects, with a low risk of serious harm.
The medication is a combination drug used to treat hypertension, or high blood pressure. It combines amlodipine, a calcium channel blocker, with olmesartan medoxomil, an angiotensin II receptor blocker.
According to the recall notice, quality testing found a problem with one of the medication's two active ingredients, olmesartan.
The recalled tablets were manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories LLC, based in Bedminster, New Jersey.
The recall is for the 30-count bottles with National Drug Code 67877-500-30, lot number 25121311, and an expiration date of March 31, 2028. The product has been distributed nationwide in the United States since Aug. 11, 2025, according to the recall notice.
The recall was initiated July 8 and remains ongoing.
NTD reached out to Ascend Laboratories for comment but did not receive a response before publication.
