Olmesartan Blood Pressure Pills Recalled: Check Your Bottle

Macleods Pharma USA is recalling thousands of bottles of a prescription blood pressure pill sold nationwide after the medication failed a federal quality test. The recall covers two lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, and the FDA has classified it as a Class II action — meaning the pills could cause temporary or reversible health problems, though serious harm is considered unlikely.

What happened

The New Jersey-based manufacturer pulled the product after it failed to meet federal quality standards, according to the U.S. Food and Drug Administration. The specific reason listed by the FDA is “failed dissolution specifications” — in plain terms, the pills did not break down as required during testing.

The recall covers two lots:

• Lot 12251163A — 3,528 bottles of 30 tablets, NDC 33342-246-07
• Lot 12251163B — 216 bottles of 90 tablets, NDC 33342-246-10

Both lots carry an expiration date of May 31, 2027. Macleods began the recall on Oct. 7, and the FDA classified it on Oct. 26. The action is ongoing and affects products distributed across the country.

The recall follows a similar one in September, when India-based Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets — another blood pressure drug — after that medication also failed dissolution testing, according to the FDA.

Why it matters

Dissolution is how a pill releases its medicine into the body. If a tablet doesn’t dissolve as specified, the amount of drug absorbed can differ from what was tested and approved. For a three-drug combination pill taken daily to control blood pressure, that variability is the concern the FDA’s Class II label is meant to capture: a real but generally not severe risk.

This suggests the practical issue for patients is consistency of effect rather than acute danger. The FDA’s classification states that serious health consequences are considered remote.

Key facts at a glance

What this means for you

• Check your bottle. Look at the label for the lot number and NDC code. If either matches the numbers above, you have an affected product.
• Don’t stop taking the medicine on your own. Blood pressure medication should not be halted abruptly; the FDA’s own classification says serious harm is unlikely, so the priority is confirming whether your supply is affected.
• Contact your pharmacist. A pharmacy can verify the lot and advise on a replacement or refill. The source does not describe a specific return or refund process.
• Watch for symptoms. If your blood pressure feels poorly controlled, speak to a clinician rather than adjusting doses yourself.

Frequently asked questions

How do I know if my olmesartan pill is recalled?

Compare the lot number and NDC code printed on your prescription bottle with the two lots listed above. Both recalled lots expire May 31, 2027.

What does “failed dissolution specifications” mean?

It means the tablets did not dissolve as required during quality testing, per the FDA. Dissolution affects how the drug is released and absorbed.

What is a Class II recall?

The FDA defines it as a situation where using the product may cause temporary or medically reversible health problems, with the chance of serious harm considered remote.

Is this the only recent blood pressure drug recall?

No. In September, Inventia Healthcare recalled 13,567 bottles of 25-milligram chlorthalidone tablets after a similar dissolution failure, according to the FDA.

What to watch next

The recall remains ongoing. The source does not say how many bottles remain in circulation, whether additional lots will be added, or what Macleods’ next steps are; the company could not immediately be reached for comment.