Blood Pressure Drug Recall: 3,744 Bottles Pulled — Check These Lot Numbers

Thousands of bottles of a common prescription blood pressure pill have been recalled across the United States — and patients are being urged to check the lot number on their bottle before their next dose.

The recall covers a generic combination tablet containing three blood pressure medicines in one pill: olmesartan medoxomil, amlodipine and hydrochlorothiazide. It is the generic version of the brand-name drug Tribenzor, which is not part of the recall.

Which bottles are affected

Macleods Pharma USA voluntarily recalled 3,744 bottles of the medication, distributed nationwide. The affected products are tablets in the strength 40 mg of olmesartan medoxomil, 10 mg of amlodipine and 12.5 mg of hydrochlorothiazide, manufactured by Macleods Pharmaceuticals Ltd. in Daman, India, for Macleods Pharma USA in Princeton, New Jersey. Both affected lots expire on 31 May 2027.

Check for these two lots:

• 30-count bottles — lot number 12251163A, NDC 33342-246-07 (3,528 bottles)
• 90-count bottles — lot number 12251163B, NDC 33342-246-10 (216 bottles)

The recall began on 7 October, and the U.S. Food and Drug Administration classified it as a Class II recall on 26 October.

Why the pills were recalled

The FDA cited "failed dissolution specifications" — the tablets did not dissolve as required during quality testing. In plain terms, a tablet that does not break down properly in the body may not lower blood pressure as well as expected, leaving a patient's condition less controlled than their doctor intended.

A Class II classification means the affected medication may cause temporary or medically reversible health problems, while the risk of serious harm is considered remote. No injuries have been reported in connection with this recall in the reports published so far.

What to do if your bottle matches

Health experts and pharmacists give the same advice for this kind of recall: do not stop taking your blood pressure medicine suddenly, because an abrupt stop can itself be dangerous. Instead, keep taking the tablets and call your pharmacist or healthcare provider promptly. They can confirm whether your supply is affected and arrange a replacement from an unaffected lot.

If your bottle's lot number does not match either of the two listed, your medication is not part of this recall. The recall affects only those two lots — not every bottle of the combination drug on the market.

This is also a useful reminder that lot numbers exist for exactly this reason. A two-minute check of the label can catch a quality problem before it becomes a health problem — and for a medicine taken every day by millions of people, that small check matters.

This article is general information only and is not medical advice.

Sources: AARP, Parade. Internal: Sanofi Killed a Promising Eczema Drug — And Nurix Shares Crashed 38%.