Olmesartan blood pressure medication recall: FDA alert across the United States

Macleods Pharma USA has recalled 3,744 bottles of a prescription blood pressure medication distributed across the United States after the tablets failed federal quality testing requirements, according to the U.S. Food and Drug Administration (FDA).

The recall involves olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, a combination medication used to treat high blood pressure and sold as a generic version of Tribenzor.

• Macleods Pharma USA has recalled 3,744 bottles of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets following failed dissolution testing.
• The FDA classified the nationwide recall as Class II, indicating potential temporary or medically reversible health consequences, with serious harm considered unlikely.
• The affected 30-count and 90-count bottles contain 40 mg/10 mg/12.5 mg tablets, carry specific lot numbers and expire on May 31, 2027.

The New Jersey-based pharmaceutical company initiated the voluntary recall on October 7, 2026, after testing identified problems with how the tablets dissolve. The FDA classified the action as a Class II recall on October 26.

According to the agency, the affected medication failed dissolution specifications, meaning the tablets did not dissolve at the required rate during testing. Such failures may affect how the active ingredients are released and potentially reduce the medication’s effectiveness.

The recall remains ongoing and covers products distributed nationwide.

Which olmesartan blood pressure medications are recalled?

The recall covers two batches of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets containing 40 mg, 10 mg and 12.5 mg of the respective active ingredients.

Consumers can identify the affected medication using the National Drug Code (NDC), lot number and expiration date printed on the packaging.

In total, the recall affects 3,744 bottles across the two packaging sizes.

The FDA has published the affected product information in its official enforcement report, allowing patients and healthcare providers to check whether specific prescription bottles are included.

FDA classifies olmesartan recall as Class II

The FDA identified the reason for the recall as “failed dissolution specifications”.

Dissolution testing evaluates whether a pharmaceutical product releases its active ingredients at the required rate. A failure to meet those standards can affect drug delivery and potentially compromise treatment effectiveness.

For blood pressure medications, inconsistent drug release raises concerns about whether patients receive the intended therapeutic effect.

The FDA assigned the recall a Class II designation, which applies when exposure to a recalled product “may cause temporary or medically reversible adverse health consequences” or when the likelihood of serious adverse consequences is remote.

The classification does not mean that every affected tablet will cause harm, but it indicates a quality issue requiring corrective action.

What should patients do if they have recalled olmesartan tablets?

Patients taking the affected medication should check their prescription packaging against the listed NDC and lot numbers.

The FDA has not issued specific consumer instructions for this recall. Patients who identify recalled medication should contact their prescribing physician or pharmacist before making changes to their treatment.

They should not independently discontinue prescribed blood pressure medication, as stopping treatment without medical guidance may leave hypertension inadequately controlled.

Anyone experiencing health concerns while taking the affected tablets should consult their healthcare provider.

Another blood pressure medication recalled after dissolution failures

The Macleods Pharma USA action follows another nationwide recall involving blood pressure medication that failed dissolution testing.

In September 2026, India-based Inventia Healthcare recalled 13,567 bottles of 25 mg chlorthalidone tablets after the medication failed to meet dissolution specifications, according to the FDA.

Chlorthalidone is a prescription medication used to treat high blood pressure.

Both recalls involved pharmaceutical quality testing failures related to tablet dissolution, although they concerned different medications and manufacturers.

The FDA continues to list the Macleods Pharma USA olmesartan combination tablet recall as ongoing, with the affected products identified by their packaging sizes, lot numbers and May 31, 2027 expiration dates.