The FDA has classified the recall as Class II after tests found that combined amlodipine and olmesartan tablets failed dissolution specifications, raising concerns about the drugs' ability to dissolve properly.

More than 11,000 bottles of a widely used blood pressure medication are being recalled across the United States following concerns over the product's quality, according to a notice published by the US Food and Drug Administration (FDA).

The recall affects 11,424 bottles of combined amlodipine and olmesartan medoxomil tablets, manufactured by India-based Alkem Laboratories Ltd. and distributed in the US by New Jersey-based Ascend Laboratories.

The affected medication comes in a strength of 10mg/40mg and is commonly prescribed to people living with high blood pressure, also known as hypertension.

According to the FDA notice, the affected batch carries lot number 25120696 and has an expiration date of December 31, 2026.

The company initiated the recall on October 6, 2026, after the tablets reportedly failed to meet required dissolution specifications.

Dissolution testing measures how quickly and effectively a drug breaks down and releases its active ingredients under controlled conditions. When a medication fails this test, there may be concerns about whether the body can absorb the medicine as intended.

The FDA classified the recall as Class II on October 16, indicating that exposure to the affected product could cause temporary or medically reversible health consequences, although the likelihood of serious harm is considered remote.

FDA Issues Guidance to Patients

Although the recall has raised concerns among patients who depend on the medication to control their blood pressure, the FDA advises consumers not to stop taking recalled medicines without first consulting a healthcare professional.

The agency explains that abruptly discontinuing prescribed medication could pose a greater health risk than continuing to use a recalled product in some circumstances.

Patients who have purchased or are currently taking the affected medication are therefore advised to contact their doctors or pharmacists for guidance.

The recall notice did not provide further details about what consumers should do with the affected bottles, and Ascend Laboratories had not issued a separate public statement at the time of the report.

Another Blood Pressure Drug Also Recalled

The FDA notice also highlighted a separate recall involving another combination medication used to manage high blood pressure.

The second recall affects tablets containing olmesartan medoxomil, amlodipine and hydrochlorothiazide, manufactured by India-based Macleods Pharmaceuticals Ltd. for Macleods Pharma USA Inc.

ALSO READ:US FDA Approves $40-a-Year Generic HIV Prevention Injection for 120 Countries 
https://dailyobserver.ng/us-fda-approves-40-a-year-generic-hiv-prevention-injection-for-120-countries

The affected products failed to meet dissolution specifications, prompting the company to recall thousands of bottles.

The recall covers 3,528 bottles containing 30 tablets each, carrying lot number 12251163A, as well as 216 bottles containing 90 tablets each, carrying lot number 12251163B.

Both products have an expiration date of May 31, 2027.

The company initiated the second recall on October 7, while the FDA classified it as Class II on October 26, 2026.

Why These Medications Matter

Amlodipine and olmesartan are commonly combined to treat hypertension. Amlodipine helps relax blood vessels, while olmesartan blocks the action of a hormone that causes blood vessels to narrow.

Together, the medicines help lower blood pressure and reduce the workload on the heart, potentially lowering the risk of serious complications such as heart attacks and strokes.

Hydrochlorothiazide, included in the second recalled medication, is a diuretic that helps the body remove excess salt and water, further assisting in blood pressure control.

The recalls highlight the importance of pharmaceutical quality checks, particularly for medications used by millions of people to manage long-term health conditions.

.

.

.

For news placements, adverts and other sponsorship, contact Daily Observer on: ( dailyobservermedia@gmail.com or +2348162850062 )