Check Your Pills in the Major Olmesartan Recall

4 min read

Macleods Pharma USA recalled 3,744 bottles of a blood pressure pill sold across the United States. The tablets failed a lab test that checks how they dissolve.

Key Points

The recall covers olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets from one batch.
The Food and Drug Administration (FDA) listed it as a Class II recall on October 26, 2026.
Patients should check their bottle and talk to a pharmacist before stopping any medicine.

Which Olmesartan Tablets Are Recalled

The recall affects one three-in-one pill that combines olmesartan medoxomil, amlodipine and hydrochlorothiazide. Doctors prescribe it to lower high blood pressure.

The pills “failed dissolution specifications,” Tampa television station FOX 13 reported, citing the FDA. That means they did not break down in testing as expected.

If a pill does not dissolve properly, the body may not absorb the right amount of medicine.

Good to know. Only two lots are part of this recall. Most people taking this medicine are not affected.

Lot Numbers to Check

Look at the label on your bottle. Compare the lot number and the National Drug Code (NDC) with the table below.

Bottle size	Lot number	National Drug Code (NDC)	Bottles recalled	Expires
30 tablets	12251163A	33342-246-07	3,528	May 31, 2027
90 tablets	12251163B	33342-246-10	216	May 31, 2027

Macleods started the recall on October 7. The FDA classified it on October 26, and the recall is still ongoing. You can search all recalls in the FDA Enforcement Reports page.

3,744Bottles recalled across two lots, based on figures reported by FOX 13.

What a Class II Recall Means

The FDA uses three recall classes. Class I is the most serious, and Class III is the least likely to cause harm. A Class II recall means the product may cause temporary or reversible health problems.

In this class, the FDA considers the chance of serious harm remote. Still, blood pressure medicine needs to work every day to protect your heart and brain.

Find the lot number on your pill bottle
Compare it with lots 12251163A and 12251163B
Call your pharmacy if it matches
Keep taking your medicine until your doctor says otherwise

Do you check lot numbers when you hear about a drug recall?

Always
Sometimes
Never thought about it

What to Do If You Have the Recalled Pills

First, do not panic, and do not stop your medicine on your own. Stopping blood pressure pills suddenly can be risky.

Instead, call your pharmacy or doctor. Ask whether your bottle comes from the recalled lot and whether they can replace it.

Your pharmacist can often switch you to a different batch or another approved version. You can also learn more about recalls on the FDA recalls page.

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When to Get Help

High blood pressure can turn dangerous. A reading of 180 over 120 or higher may be a hypertensive crisis, according to Cleveland Clinic.

Call 911 if your reading is that high and you notice any of these signs.

Chest pain or a racing heartbeat
A severe headache or dizziness
Sudden blurry vision or vision loss
Slurred speech or confusion
Sudden weakness in the arms or legs, or a drooping face

If you have no symptoms, rest for a few minutes and check again. If it stays high, contact a doctor.

Another Recent Recall

This is not the only blood pressure recall this fall. In September, Inventia Healthcare recalled 13,567 bottles of chlorthalidone tablets after they also failed dissolution testing, according to the FDA.

Winter can also affect heart health. Read our guide to winter habits that boost your immunity for simple daily routines.

Try this today. Take a photo of the labels on all your prescription bottles. It makes checking future recalls quick and easy.

Frequently Asked Questions

Why was the olmesartan combination pill recalled?

The tablets failed a dissolution test, so they may not release medicine in the body as expected.

Should I stop taking my blood pressure medicine?

No. Do not stop on your own. Talk to your pharmacist or doctor first.

How do I know if my bottle is part of the recall?

Check the lot number on the label. The recalled lots are 12251163A and 12251163B. Our guide on flu, cold and coronavirus disease (COVID) symptoms covers other winter health questions.

This article is for information only and is not medical advice. Always follow your doctor’s guidance.

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Editor’s Note

This story is accurate as of November 7, 2026, based on the recall details the FDA shared. Recall details can change, so check with your pharmacist for the latest information.

Spot an error in this article? Please contact us at support@digieh.com or read our Corrections Policy.

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