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Nationwide recall issued for more than 3,700 bottles of blood pressure medicine after quality failure

Digilifetrends Published 2 min read

Thousands of bottles of a widely used blood pressure medicine have been pulled from shelves across the country after the tablets failed an important quality test.

The Food and Drug Administration said the affected products may not dissolve as they should, which could put patients at risk.

A close-up of a person's hands holding a supplement bottle to read the label in a store.
Thousands of blood pressure medication bottles face a nationwide recall after failing quality tests (stock image)
Young man spilling multiple pills in his hand.
The FDA warned that the affected prescription drugs might not dissolve properly for patients (stock image)

Macleods Pharma USA, based in New Jersey, voluntarily began the recall, affecting 3,744 bottles of prescription medication distributed nationwide.

The products involved are Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide tablets, which are prescribed to treat hypertension, or high blood pressure.

According to the FDA, the medication did not meet dissolution requirements, raising questions about how the tablets break down in the body.

The agency described the issue as a failure to meet dissolution specifications.

That means the pills did not break down properly during testing, which could affect how the medicine is absorbed.

The FDA later classified the recall as Class II.

Under that designation, use of the affected medication may lead to temporary or medically reversible health effects, while the chance of serious harm is considered remote.

The recall includes 3,528 bottles of 30 tablets each and another 216 bottles containing 90 tablets.

Both versions contain the same three-drug combination, with strengths of 40 mg, 10 mg and 12.5 mg.

The 30-count bottles are identified by lot number 12251163A and National Drug Code (NDC) 33342-246-07.

The 90-count bottles carry lot number 12251163B and NDC 33342-246-10.

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

Patients are being urged to compare their prescription bottles with the listed lot numbers.

However, they should not stop taking prescribed blood pressure medication without first speaking with a doctor or pharmacist, since abruptly ending treatment could leave their condition uncontrolled.

The FDA said the recall is still ongoing and that the affected products were distributed nationwide.

The tablets were manufactured by Macleods Pharmaceuticals Ltd. in India for Macleods Pharma USA in Princeton, New Jersey.

According to the FDA enforcement report, the company has not issued a public press release about the recall.

The FDA has not announced when the recall will end.

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