Nationwide recall issued for thousands of bottles of a three-drug blood pressure medicine after quality test failure

If you use a combination blood pressure medication, it may be a good idea to check the bottle. Nearly 3,800 bottles of a generic three-in-one blood pressure drug have been recalled across the country after laboratory testing found that the tablets did not dissolve properly.

Key takeaways

• Macleods Pharma USA has recalled 3,744 bottles of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 mg/10 mg/12.5 mg, the generic version of Tribenzor.
• The recall was triggered by “failed dissolution specifications,” meaning the tablets did not break down as expected during testing, which could affect how much medicine the body absorbs.
• The FDA listed the recall as Class II on October 26, 2026, indicating the product could cause temporary or medically reversible health effects, while serious harm is considered unlikely.
• The affected bottles were shipped nationwide. Only two lots are involved, and both expire on May 31, 2027.
• Do not stop taking your blood pressure medicine on your own. Check the bottle, then contact a pharmacist or doctor about a replacement.

What was recalled

Macleods Pharma USA, based in New Jersey, initiated the recall on October 7, 2026. The FDA classified it on October 26, and the action remains ongoing.

Look for these details on the bottle:

The label will identify the product as olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 mg/10 mg/12.5 mg. If your pharmacy repackaged the pills into its own container, the lot number may not appear on the label. A pharmacist can help confirm it.

Macleods has not released a press statement or consumer guidance.

Why dissolution matters

Before a tablet can work, it must break down in the digestive system so the medicine can enter the bloodstream. Dissolution testing checks whether tablets release their active ingredients at the proper rate.

If a tablet fails that test, it may release the drug too slowly or unevenly. For a blood pressure medication, that could mean blood pressure is not controlled as well as it should be. The FDA’s Class II designation means the chance of serious harm is considered low.

This medication combines three blood pressure treatments in one tablet:

• Olmesartan, an angiotensin II receptor blocker (ARB) that relaxes blood vessels
• Amlodipine, a calcium channel blocker that widens arteries
• Hydrochlorothiazide, a diuretic, or “water pill,” that helps the body eliminate extra salt and water

What to do

• Check your bottle for the NDC and lot numbers above.
• Continue taking the medicine until you have spoken with a pharmacist or doctor. Stopping blood pressure medication abruptly can raise blood pressure and increase the risk of heart attack or stroke.
• Call your pharmacy. Ask whether your prescription came from a recalled lot and whether it can be replaced with a different lot or manufacturer.
• Monitor your blood pressure at home if you have a cuff, and tell your doctor if your readings are higher than usual.
• Get urgent help if you notice symptoms of severely high blood pressure, including a bad headache, chest pain, shortness of breath, vision changes, confusion, or weakness on one side of the body.
• Report any issues through the FDA’s MedWatch program.

Not the first blood pressure drug recall this fall

This recall comes after several other generic blood pressure medication recalls in 2026. In September, Inventia Healthcare of India recalled more than 13,500 bottles of 25 mg chlorthalidone tablets for the same reason: failed dissolution testing. Recalls like these are a reminder to review any notices sent by your pharmacy.

This article is not a substitute for medical advice. Speak with your doctor or pharmacist if you have concerns about your medication.

Sources:

• U.S. Food and Drug Administration. Enforcement Report: Macleods Pharma USA, olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, classified October 26, 2026.
• Fox Business: Thousands of blood pressure medication bottles recalled nationwide after pills fail quality test.
• The Healthy: FDA: More than 3,000 bottles of blood pressure drug recalled nationwide.