FDA Classifies Nationwide Recall of Blood Pressure Medication

The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of certain lots of a generic blood pressure medication manufactured by Macleods Pharma USA. The recall involves over 3,700 bottles of the medication after it failed a quality test.

Recall Details and Classification

Macleods Pharmaceuticals initiated the recall on October 7. The FDA designated the recall as Class II on October 26, according to an enforcement report. A Class II designation means there is a "remote probability that using the products will cause serious adverse health consequences," and that using the affected products may cause "temporary or medically reversible health consequences," although the agency considers serious adverse outcomes unlikely.

According to the FDA enforcement report, the recall applies to 3,528 30-count bottles and 216 90-count bottles of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets. The medication was distributed nationwide between November 21, 2025, and April 27, 2026.

Product Identification

The recalled medication is a combination of three active ingredients: olmesartan medoxomil, amlodipine, and hydrochlorothiazide. The affected products have a strength of 40 mg/10 mg/12.5 mg and an expiration date of May 31, 2027.

Specific product details include:

• 30-count bottles: NDC 33342-246-07, lot number 12251163A.
• 90-count bottles: NDC 33342-246-10, lot number 12251163B.

The medication is a generic version of a medication commonly associated with the brand name Tribenzor, but the brand-name medication is not included in this recall.

Manufacturing and Efficacy Concerns

The recall was prompted by failed dissolution testing requirements. Dissolution testing is used to assess drug quality by evaluating how well a drug dissolves and releases its active ingredients when placed in liquid. The identified manufacturing defect involves failed dissolution specifications, meaning the tablets may not release their active ingredients into the body at the required rate, which could potentially reduce their effectiveness in controlling blood pressure.

According to the FDA, notification letters were sent to businesses and individuals who may have received the affected medication. The agency did not issue a separate news release announcing the recall.

Guidance for Consumers

Patients who are unsure if they have the recalled version should verify the product information. For Class II drug recalls, consumers can generally continue taking their medication unless the manufacturer or FDA provides different instructions. The FDA advises patients to consult their healthcare providers before making changes to their medication routines.

If the lot number does not appear on the pill bottle, consumers should contact their pharmacy.

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Sources

• newsday.com: Blood pressure medication recalled: Check your pills - Newsday
• aol.com: Popular blood pressure medication recalled over efficacy concerns - AOL
• demokratis.co.id: FDA Classifies Nationwide Recall of Blood Pressure Medication

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.