Olmesartan Recall: Macleods Blood Pressure Pills Pulled Over Dissolution Failure; Check These Lot Numbers

This article is for general information only and is not medical advice. Don’t stop or change any medicine without talking to your doctor or pharmacist.

A generic blood pressure medicine that contains olmesartan has been recalled nationwide. Macleods Pharmaceuticals is pulling more than 3,700 bottles of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets because they failed dissolution testing, USA Today reported. That means the pills may not release their active ingredients at the right rate, so they might not lower blood pressure as well as they should.

The FDA classified the recall as Class II on Oct. 26, according to USA Today. The company first started the recall on Oct. 7.

Which olmesartan tablets are recalled?

The recall covers one strength of the three-drug combination pill, made for Macleods Pharma USA of Princeton, New Jersey, by Macleods Pharmaceuticals in India:

In total, 3,528 30-count bottles and 216 90-count bottles are affected. They were distributed nationwide, according to the FDA enforcement report summarized by RecallWeekly. No illnesses were listed.

Is Tribenzor recalled?

No. Tribenzor is the brand name for this drug combination, and USA Today reported that brand-name Tribenzor is not part of the recall. If you’re not sure whether your pharmacy gives you the brand or a generic, check the label or ask your pharmacist.

Another olmesartan combination recall in October

A separate Class II recall is listed in the FDA’s enforcement records. Ascend Laboratories recalled one lot of amlodipine and olmesartan medoxomil tablets, 10 mg/40 mg (30 tablets, NDC 67877-502-30, lot 25120696, exp. Dec. 31, 2026), also for dissolution problems, RecallWeekly reported. That recall, dated Oct. 16, covers 11,424 bottles made by Alkem Laboratories in India.

What does “failed dissolution” mean?

Dissolution testing checks how a tablet breaks down and releases its medicine. If a pill fails, the drug may be absorbed too slowly or unevenly. For a blood pressure medicine, USA Today explained, the result could be that it doesn’t control blood pressure as expected.

What should patients do?

Based on the guidance in the sources:

1. Check your bottle. Compare the product name, strength, NDC and lot number with the table above.
2. Don’t just stop taking it. The recall guidance summarized by RecallWeekly says not to stop your blood pressure medicine without talking to your doctor or pharmacist. USA Today notes that with a Class II drug recall, consumers can generally keep using the medicine unless the company or FDA says otherwise.
3. Call your pharmacist or doctor. They can tell you whether your supply is affected and arrange a replacement or an alternative.
4. Return recalled medicine to your pharmacy if your pharmacist tells you to.

The FDA didn’t issue a news release for this recall. According to USA Today, notification letters went to affected businesses and people.

What is a Class II recall?

According to USA Today, the FDA uses Class II when use of a product may cause temporary or medically reversible health problems, but serious harm is unlikely.

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