FDA Announces Nationwide Recall of More Than 3,000 Bottles of Blood Pressure Medication

According to a new report, there are signs that the medicine may not perform exactly as intended.

Treating high blood pressure is not always as simple as relying on a single prescription. Harvard Health says as many as 30% of people with hypertension need three separate medications to help control it.

One option is a combination drug that pairs olmesartan and amlodipine, which help relax blood vessels, with hydrochlorothiazide, a diuretic that helps the body remove extra salt and water.

The U.S. Food and Drug Administration is now reporting a nationwide recall of this three-drug blood pressure treatment because of a quality problem.

Recall details

Macleods Pharma USA, Inc. is recalling 3,744 bottles of blood pressure medicine nationwide after the product failed dissolution specifications, suggesting the tablets may not have dissolved as expected during testing. That could affect how the body absorbs the drug.

In a report dated October 26, the FDA classified the recall as Class II, which it defines as a drug that “may cause temporary health consequences, but the probability of a serious health issue is remote.”

The FDA said the affected products can be identified as follows:

Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg), 30-count bottle

• NDC: 33342-246-07
• Lot number: 12251163A
• Expiration date: 05/31/2027

Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg), 90-count bottle

• NDC: 33342-246-10
• Lot number: 12251163B
• Expiration date: 05/31/2027

The recall is the latest in a string of blood pressure drug withdrawals reported in recent months. One earlier recall covered 13,000 bottles of chlorthalidone, while another affected more than 21,000 bottles of a different combination blood pressure pill.

Macleods Pharma has not released a press statement or provided specific instructions for consumers. Still, the FDA says people can generally keep taking medications involved in Class II recalls, although patients should first check with their doctor or pharmacist for advice.