WASHINGTON, DC — A nationwide recall has been issued for 3,744 bottles of a blood pressure medication after regulators said the product failed dissolution specifications. The U.S. Food and Drug Administration said the problem could affect how the medicine releases its active ingredients in the body, raising concerns that it may not work as intended.
The voluntary recall was started by Macleods Pharma USA, Inc. on Oct. 7 and later classified by the FDA as Class II on Oct. 26. That designation means use of the affected product may cause temporary or medically reversible health consequences. The medication is olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, a generic version of Tribenzor.
Which bottles are included in the recall
The recall covers 3,528 bottles in 30-count packaging and 216 bottles in 90-count packaging. Both versions are olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in the 40 mg/10 mg/12.5 mg strength.
Consumers checking their medication should look for the following details: the 30-count bottles carry NDC 33342-246-07 and lot number 12251163A, while the 90-count bottles carry NDC 33342-246-10 and lot number 12251163B. The expiration date on both products is May 31, 2027.
The FDA said more information is available in its enforcement report, which lists the recalled product details. Anyone with this medicine at home should compare the label carefully before using it.
Why the FDA says the medicine is a concern
The key issue is dissolution, the process that determines how a drug breaks down and releases its active ingredients once swallowed. According to the FDA’s notice, the tablets failed that testing standard.
That does not mean every pill is instantly unsafe, but it does mean the medication may not deliver the expected amount of medicine into the body at the proper rate. For a treatment such as blood pressure control, inconsistent release can be a serious quality problem because the medicine may be less effective than expected.
The FDA’s Class II label reflects that the agency views the risk as significant enough to merit attention, but not at the level of a recall linked to severe or life-threatening injury. Even so, patients should not assume the pills will perform normally if they are part of the affected lots.
What patients should do before stopping treatment
The FDA has not announced a specific consumer disposal instruction for the recalled bottles. Until more guidance is issued, patients are being told to contact the prescribing doctor before stopping the medicine on their own.
That advice matters because blood pressure drugs are often used daily and stopping abruptly can create its own risks. If someone has already been taking tablets from one of the affected bottles and notices any health concerns, they should speak with a medical professional right away.
People should not rely on appearance alone to determine whether a bottle is part of the recall. The safest check is to match the exact drug name, strength, package size, NDC number and lot number against the recall notice.
Macleods Pharma initiated the recall on Oct. 7
Macleods Pharma USA, Inc. began the recall on Oct. 7 after identifying the dissolution issue. The company’s decision set off the formal process that later drew the FDA’s Class II classification on Oct. 26.
The recall is voluntary, which means the company took the action itself rather than waiting for an ordered removal. Still, once the FDA posts a recall and assigns a risk class, the notice becomes the main reference point for pharmacies, distributors and patients trying to identify affected stock.
Because the product is a generic version of Tribenzor, patients may be taking it under a different label than the brand-name drug. That makes the exact label information especially important when checking home supplies or pharmacy records.
How to check a home medicine cabinet for the recalled product
Consumers who take blood pressure medication should start by finding the bottle and reading the full product name. The affected medicine is olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets at 40 mg/10 mg/12.5 mg.
Next, compare the package size and lot details. A 30-count bottle with NDC 33342-246-07 and lot number 12251163A, or a 90-count bottle with NDC 33342-246-10 and lot number 12251163B, is included in the recall if the expiration date is May 31, 2027.
If the bottle matches, the next step is to call the prescribing physician or pharmacist for guidance. Patients should keep taking the medicine only under medical advice until they know whether their prescription is affected.
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