Olmesartan recall: Is my medication affected and what should I do?

What was recalled and who is affected

The recall concerns a specific Olmesartan Medoxomil, amlodipine, and hydrochlorothiazide tablet formulation used to treat high blood pressure. The medication is sold under the generic name Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets, and is associated with two bottle sizes in this recall:

30-count bottles: NDC 33342-246-07, lot number 12251163A, expiration date 05/31/2027. There were 3,528 bottles in this size recalled.

90-count bottles: NDC 33342-246-10, lot number 12251163B, expiration date 05/31/2027. There were 216 bottles in this size recalled.

The brand-name Tribenzor is not recalled, but if you are or were taking it and aren’t sure whether your medication is the generic version included in the recall, verify the NDC and lot numbers against the ones listed above.

Why the recall happened

The U.S. Food and Drug Administration (FDA) lists the reason for the recall as “failed dissolution specifications.” This means the pills did not release their active ingredients at the expected rate during testing, which can render the medication less effective at lowering blood pressure. The recall was initiated by Macleods Pharma USA, a New Jersey–based company, and the action was classified by the FDA as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences, but is unlikely to cause serious health issues.

FDA communication and what Class II means for you

The FDA did not issue a nationwide press release for this recall. Instead, letters were sent to notify businesses and individuals who may have received the affected medication, and the recall was posted in the FDA enforcement report. For Class II recalls, the FDA generally indicates that consumers can continue using the medicine unless the recalling company or FDA advises otherwise, but you should still consult your healthcare provider before making changes to your medication routine.

Context: is this a one-off issue or part of a broader pattern?

In the weeks surrounding this recall, a related issue emerged in another blood pressure medication: Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets after they failed dissolution testing. This nearby action, reported against another drug in the same class, suggests a broader pattern of quality-control challenges affecting dissolution specifications in certain BP medications. This context helps answer the implicit question: is this an isolated incident or part of a larger trend?

How to check your medicine

To determine whether your medication is part of the recall, examine the bottle for the following identifiers: the 30-count bottles carry NDC 33342-246-07 with lot number 12251163A and expiration 05/31/2027; the 90-count bottles carry NDC 33342-246-10 with lot number 12251163B and the same expiration date. If your bottle matches these NDCs and lot numbers, you should assume it’s within the recall scope and take action as described below.

What to do if your medication is recalled

First, do not stop taking the medication abruptly without speaking to a healthcare professional. If you determine your bottle is part of the recall, contact your healthcare provider to discuss alternatives or a replacement prescription. Also consider consulting your pharmacist or the dispensing pharmacy about next steps. The FDA enforcement report and the recall notices from the manufacturer provide the official details about the scope of the recall.

For consumers who are unsure whether their specific product is recalled, verify the NDC and lot number on the bottle and compare them to the numbers above. If in doubt, contact your healthcare provider for guidance before making changes to your treatment plan.

Brand-name versus generic considerations

Tribenzor, the brand-name product, is not recalled. If you are taking Tribenzor and are unsure whether your medication is the recalled generic version, check the NDCs listed above and confirm with your pharmacist or prescriber.

Notes on commentary and comment status

Reports noting the recall indicate that Macleods Pharma USA could not immediately be reached for comment at the time of reporting. If you are tracking official statements, rely on FDA enforcement postings and the manufacturer’s recall notices for the most accurate, up-to-date information.