FDA recalls batches of combination blood pressure medication over quality and dissolution concerns

Federal health regulators and pharmaceutical manufacturer Macleods Pharma USA have issued a nationwide recall for select lots of a widely prescribed blood pressure medication after quality testing revealed the tablets failed to meet standard dissolution specifications.

The recall covers 3,744 bottles of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (40 mg / 10 mg / 12.5 mg) distributed across the United States. The action has been designated as a Class II recall by the U.S. Food and Drug Administration (FDA), a classification defined as a situation where exposure to the product may cause temporary or medically reversible adverse health consequences, while the risk of severe harm remains remote.

What Prompted the Recall?

According to FDA enforcement notices, routine laboratory testing determined that the olmesartan component of the triple-combination therapy failed dissolution testing. Dissolution tests evaluate how reliably a tablet breaks down and releases its active compounds in the digestive tract.

When a tablet fails to dissolve within required clinical parameters, the body may absorb the medication incompletely or too slowly. For hypertension patients, this could lead to under-dosing and a temporary loss of blood pressure control.

Affected Prescription Lots

Patients taking combination olmesartan/amlodipine/hydrochlorothiazide tablets are urged to check the Lot Number, Expiration Date, and National Drug Code (NDC) printed on their prescription bottles:

• 30-Count Bottles:

  • NDC: 33342-246-07

  • Lot Number: 12251163A

  • Expiration Date: May 31, 2027

    (Total scope: 3,528 bottles)

• 90-Count Bottles:

  • NDC: 33342-246-10

  • Lot Number: 12251163B

  • Expiration Date: May 31, 2027

    (Total scope: 216 bottles)

The recalled batches were distributed nationwide between late November 2025 and April 2026.

Guidance for Patients

Medical professionals and pharmacists emphasize that patients should not abruptly stop taking their blood pressure medication without consulting their physician or dispensing pharmacy. Suddenly discontinuing anti-hypertensive therapy can cause a dangerous spike in blood pressure (rebound hypertension).

Consumers who find they possess bottles from either recalled lot should contact their pharmacist immediately to secure an alternative, compliant batch or replacement prescription.

Community Consumer Advisory: What You Need to Know

• Medication Recalled: Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (40 mg / 10 mg / 12.5 mg).

• Manufacturer: Macleods Pharma USA.

• Reason: Failed dissolution testing, which can prevent the pills from properly dissolving and releasing the active medicine, reducing effectiveness.

• Lots to Check:

  • Lot 12251163A (30-count bottles, Exp. 05/31/2027)

  • Lot 12251163B (90-count bottles, Exp. 05/31/2027)

• Action Required: Do not halt medication cold turkey. Check your bottle’s label, and contact your prescribing doctor or local pharmacy for a replacement if your bottle matches either affected lot.