Olmesartan Recall: FDA Names Two Blood Pressure Drug Lots
Conceptual artwork using generic, fictional medicine packaging.
The FDA has classified a US recall of 3,744 bottles as Class II after two lots of a combination blood-pressure medicine failed a dissolution test.
Patients taking olmesartan medoxomil with amlodipine and hydrochlorothiazide should check the lot number on the bottle after the US Food and Drug Administration classified a recall involving 3,744 bottles. The affected combination tablets failed dissolution specifications, a quality test that measures how a medicine releases into solution.
The FDA’s enforcement record identifies two lots distributed nationwide by Macleods Pharma USA. The regulator classified the action as Class II on 26 October, a category for situations where temporary or medically reversible health effects may occur, with a low probability of serious consequences.
Which olmesartan lots are included in the recall?
The FDA lists lot 12251163A in a 30-count bottle, product code NDC 33342-246-07, with 3,528 bottles affected. Lot 12251163B came in 90-count bottles, NDC 33342-246-10, with 216 bottles affected. Both lots carry an expiry date of 31 May 2027.
The agency’s enforcement report says the recall began on 7 October and covers products distributed across the United States. The FDA assigned the Class II classification on 26 October. The two quantities add to 3,744 bottles.
Olmesartan is an angiotensin II receptor blocker used to treat high blood pressure. The recalled product combines it with amlodipine and hydrochlorothiazide, medicines that work through different mechanisms to help lower blood pressure. A dissolution failure describes how a tablet performs in a laboratory test; the FDA record identifies the quality issue and classification, while an individual patient’s care depends on their clinician.
What does an FDA Class II recall mean?
The FDA describes Class II recalls as situations where use of, or exposure to, a product may cause temporary or medically reversible health effects, while the likelihood of serious adverse effects remains remote. That classification measures the regulator’s assessment of the recall risk, rather than a diagnosis for every person who took the medicine.
Two independent reports, from Fox Business and The Independent, also identify the dissolution test as the reason and report the two affected lots. The FDA’s recall guidance explains that consumers should follow the recall notice and contact a health professional about the product.
The regulator’s listing covers the United States. A Taiwan FDA notice says checks found the specific batches absent from Taiwan’s import records, illustrating why patients elsewhere should check national regulator notices and ask a pharmacist to identify the manufacturer and lot before drawing conclusions about local supply.
What should patients do now?
Read the label on the medicine bottle and compare the product, strength, National Drug Code and lot number with the FDA record. The recall concerns the combination tablet at 40mg/10mg/12.5mg strength, in the two listed lots.
If the bottle matches, contact the dispensing pharmacy or prescriber promptly and ask how to obtain replacement medicine. Patients should keep the packaging available when calling so a pharmacist can confirm the lot and advise on the next prescription.
People taking blood-pressure medicine should speak with a doctor or pharmacist before changing or stopping treatment. The FDA advises patients to follow the specific recall instructions and consult a health professional about questions involving their medicine. Anyone experiencing a concerning symptom should seek medical care.
Patients outside the United States can ask a local pharmacist to check the manufacturer, batch and national safety notices. The FDA record identifies US distribution; the listing gives overseas patients a reason to check their national regulator’s notice and confirm any locally supplied batch with a pharmacist.
Frequently asked questions
Which medicine was recalled?
The recall covers olmesartan medoxomil, amlodipine and hydrochlorothiazide combination tablets, strength 40mg/10mg/12.5mg, in two specific lots.
What are the affected lot numbers?
The FDA lists 12251163A in 30-count bottles and 12251163B in 90-count bottles. Check the bottle label against the FDA record.
Should patients stop taking the medicine?
Patients should contact their doctor or pharmacist before changing or stopping prescribed blood-pressure treatment and ask about a safe replacement if their lot matches.
What does Class II mean?
The FDA says a Class II recall involves possible temporary or medically reversible health effects, with a low likelihood of serious consequences.
Does the recall apply outside the United States?
The FDA record covers US distribution. Patients elsewhere should check their national regulator’s notices and confirm the product and batch with a pharmacist.