Blood Pressure Pill Recall: Macleods Pulls 3,744 Bottles Nationwide After Tablets Fail FDA Dissolution Test

Thousands of bottles of a prescription blood pressure medication have been recalled nationwide after the tablets failed a federal quality test, according to the U.S. Food and Drug Administration.

Macleods Pharma USA recalled 3,744 bottles of a combination blood pressure medication distributed nationwide because the tablets may not dissolve properly.

What's affected

The recall involves a generic combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, containing the same three active ingredients as brand-name Tribenzor. Tribenzor-branded medication is not listed in the recall.

The recall covers tablets containing 40 mg of olmesartan medoxomil, 10 mg of amlodipine and 12.5 mg of hydrochlorothiazide.

Two lots are included. The recall covers 3,528 bottles of 30 tablets under lot number 12251163A, NDC 33342-246-07, and 216 bottles of 90 tablets under lot number 12251163B, NDC 33342-246-10.

Both batches expire May 31, 2027, and were distributed nationally between Nov. 21, 2025, and April 27, 2026.

The medication was made by Macleods Pharmaceuticals Ltd. in Daman, India, for Macleods Pharma USA in Princeton, New Jersey.

Why it was recalled

The FDA listed the reason as "Failed Dissolution Specifications," meaning the tablets didn't meet required standards for how they dissolve.

That could affect how well the drug works. The manufacturer says the tablets could reduce or delay absorption of olmesartan, potentially causing a temporary dip in blood pressure control.

Risk level

Macleods initiated the recall Oct. 7, and the FDA classified it Oct. 26. The FDA classified it as a Class II recall. The recall remains ongoing.

What patients should do

Patients should check the lot number on their medication and contact their pharmacist or health care provider before stopping treatment. Stopping blood pressure medication abruptly can be risky, so experts advise against discontinuing it without medical guidance.

Identifying the maker can be tricky. Because this is a generic medication, the manufacturer's name may vary, so patients should look for Macleods Pharma USA or Macleods Pharmaceuticals Ltd. on the packaging.

Part of a broader trend

The recall follows a September recall in which India-based Inventia Healthcare pulled 13,567 bottles of 25-milligram chlorthalidone tablets after they also failed dissolution testing.

It is not Macleods' first recall this year. In February 2026, Macleods Pharma USA recalled 1,315 bottles of levothyroxine sodium, a thyroid medication.