More Than 11,000 Bottles of Blood Pressure Medication Recalled Nationwide After Failing FDA Quality

Ascend Laboratories is recalling 11,424 bottles of amlodipine and olmesartan medoxomil tablets after testing found the medication failed dissolution specifications, potentially affecting how the drug releases into the body.

By yourNEWS Media Newsroom

A New Jersey-based pharmaceutical company has recalled more than 11,000 bottles of a prescription medication used to treat high blood pressure after the tablets failed quality testing, according to a recall notice published by the U.S. Food and Drug Administration.

Ascend Laboratories LLC initiated the voluntary recall of 11,424 bottles of amlodipine and olmesartan medoxomil tablets, 10 mg/40 mg, after testing identified problems with the medication’s dissolution, which measures how properly a drug dissolves and releases its active ingredients.

The recall began Oct. 6 and was published in the FDA’s enforcement report Oct. 16, according to the agency’s official recall record.

The affected medication was distributed nationwide in 30-tablet bottles and manufactured by Alkem Laboratories Ltd. in India for distribution by Ascend Laboratories in Parsippany, New Jersey.

The FDA identified the recalled medication as follows:

The FDA identified the reason for the recall as “Out of Specification results due to Dissolution.”

Dissolution testing determines whether a medication releases its active pharmaceutical ingredients at the required rate. When tablets fail these specifications, the medication may not deliver the intended amount of the active ingredient as expected, potentially reducing its effectiveness.

Amlodipine and olmesartan medoxomil is a combination prescription medication used to treat hypertension, commonly known as high blood pressure.

Amlodipine belongs to a class of medications called calcium channel blockers. It helps relax blood vessels, allowing blood to flow more easily and reducing pressure within the arteries.

Olmesartan medoxomil is an angiotensin II receptor blocker, or ARB, that prevents a hormone from constricting blood vessels. Together, the two medications lower blood pressure and reduce the cardiovascular risks associated with uncontrolled hypertension.

High blood pressure increases the risk of heart attack, stroke, kidney damage and other serious medical complications. Maintaining consistent blood pressure control is particularly important for patients who depend on daily medication.

The FDA classified the recall as Class II, indicating that exposure to the affected product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is considered remote.

The classification does not mean that every tablet in the recalled lot has caused harm. Rather, it reflects the potential risks associated with the identified manufacturing or quality defect.

Ascend Laboratories notified affected customers by letter as part of the voluntary recall.

The recall applies specifically to the identified lot of the 10 mg/40 mg combination tablets and does not automatically include every bottle of amlodipine and olmesartan medoxomil or medications manufactured by other companies.

Patients who take the medication should examine their prescription packaging and compare the lot number, strength and expiration date with the information listed in the recall.

Individuals who discover that they possess an affected bottle should contact their pharmacist or healthcare provider to determine how to obtain a replacement or alternative medication.

Patients should not abruptly stop taking prescribed blood pressure medication without consulting a healthcare professional, because uncontrolled blood pressure can increase the risk of serious cardiovascular complications.

The latest recall follows other quality-related recalls involving medications distributed by Ascend Laboratories earlier in 2026.

In July, the company recalled 6,192 bottles of amlodipine and olmesartan medoxomil tablets in the 10 mg/20 mg strength because testing identified dissolution failures and olmesartan medoxomil content below specifications.

Another recall announced in June involved 15,696 bottles of the combination medication in the 5 mg/40 mg strength, also associated with dissolution testing failures and insufficient olmesartan content.

Those earlier recalls involved separate dosage strengths and manufacturing lots and should not be confused with the newly identified 10 mg/40 mg product.

The FDA maintains a publicly accessible enforcement database containing recall descriptions, affected products, distribution information and recall classifications.

Consumers can also report medication quality problems or suspected adverse reactions through the agency’s MedWatch safety reporting program.

The current recall covers 11,424 bottles distributed throughout the United States. Patients using the 10 mg/40 mg formulation should verify whether their medication carries lot number 25120696 and consult their pharmacist if the product matches the recalled batch.