Thousands of Bottles of Blood Pressure and Heart Drugs Recalled Nationwide

The product was manufactured by India-based Alkem Laboratories and distributed by New Jersey-based Ascend Laboratories.

Bottles of drugs are filled as they move down an automated lines in a file photo. Photo by George Frey/Getty Images

A type of prescription medication used to treat high blood pressure and heart attacks is being recalled, according to an enforcement report published by the Food and Drug Administration this week.

The company said that amlodipine and olmesartan medoxomil tablets—in 10 mg and 20 mg doses, respectively—are being recalled nationwide, according to the notice. There are 30 tablets per bottle, and the bottle has the lot number 25121311 and an expiration date of March 31, 2028, it said.

The recall was initiated on July 8, but it was not published on the FDA’s website until this week.

The product was manufactured by India-based Alkem Laboratories Ltd. and distributed by New Jersey-based Ascend Laboratories, LLC, according to the report, which added that 6,192 bottles are impacted by the action.

The reason for the recall, the report said, is “failed dissolution specifications,” with the olmesartan medoxomil content being “below specifications.” Failed dissolution specifications mean that a drug doesn’t break down or dissolve at the correct timing when it is ingested, preventing the body from absorbing the active ingredient.

The FDA classified the recall as Class II on July 20, which the FDA says may include “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Amlodipine is considered a calcium channel blocker that prevents calcium from entering the cells of the heart and blood vessels, thereby widening the arteries, according to the Mayo Clinic. Meanwhile, olmesartan medoxomil is an angiotensin II receptor blocker that blocks a natural process that tightens blood vessels, allowing blood to flow more easily.

The clinic says amlodipine is generally used to treat high blood pressure, which may reduce the risk of heart attacks. It can also be used to treat chronic stable angina or vasospastic angina.

Olmesartan medoxomil is also used to treat high blood pressure and can help the heart pump blood more efficiently, according to the U.S. government’s MedicinePlus website.

Alkem Laboratories Ltd. has recalled multiple blood pressure and heart drugs in recent months.

In mid-May, the company recalled more than 17,000 bottles of metoprolol succinate extended-release tablets used to treat high blood pressure, also due to a “dissolution failure.” In September 2025, more than 140,000 bottles of the generic version of atorvastatin, a commonly used drug prescribed to treat cholesterol and heart issues, were also recalled due to a similar problem.