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A blood pressure pill is supposed to help keep a dangerous condition under control. But what happens when the medication doesn’t dissolve the way it should? That’s the concern behind a nationwide recall affecting 3,744 bottles of prescription blood pressure medication, according to the U.S. Food and Drug Administration (FDA).
New Jersey-based Macleods Pharma USA is voluntarily recalling certain lots of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, a generic combination medication used to treat high blood pressure. The recall began October 7, 2026, after the tablets failed federal quality testing.
The FDA classified the recall as Class II on October 26, indicating that the affected medication could cause temporary or medically reversible health problems, while the likelihood of serious consequences is considered remote. The recall remains ongoing, with affected products distributed throughout the United States.
Why the Pills Failed and Why It Matters
The FDA identified the problem as “failed dissolution specifications.” In simpler terms, the tablets did not dissolve as required during testing. That matters because a medication must release its active ingredients appropriately to deliver its intended treatment.
The recalled tablets combine three ingredients that help manage high blood pressure: olmesartan medoxomil, amlodipine and hydrochlorothiazide. The affected formulation contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine and 12.5 mg of hydrochlorothiazide. If the tablets do not dissolve properly, they may not lower blood pressure as expected.
The medication contains the same active ingredients as the brand-name drug Tribenzor, but brand-name Tribenzor is not included in this recall. The affected products were manufactured by Macleods Pharmaceuticals Ltd. in Daman, India, for Macleods Pharma USA in Princeton, New Jersey. The FDA’s enforcement report identifies the specific generic product and affected batches.
Check These Lot Numbers, NDC Codes, and Expiration Dates
The recall involves two specific batches of the same combination medication, packaged in different bottle sizes. Consumers should check the product name, strength, National Drug Code (NDC), lot number and expiration date rather than relying on the medication name alone.
The affected 30-count bottles have NDC 33342-246-07 and lot number 12251163A. A total of 3,528 bottles are included. The affected 90-count bottles have NDC 33342-246-10 and lot number 12251163B, covering another 216 bottles. Both lots carry an expiration date of May 31, 2027.
Those details are particularly important because the medication may still be sitting in patients’ medicine cabinets, with an expiration date months away. The FDA assigned the recall number D-0077-2027, under enforcement event 100113. Patients can review the official FDA enforcement report to verify the affected products.
What Patients Should Do if Their Medication Is Recalled
Finding a matching bottle does not mean patients should immediately stop taking their blood pressure medication. Do not discontinue prescribed treatment without first speaking to a doctor or pharmacist. Stopping blood pressure treatment without medical guidance can create its own health risks.
Patients whose bottles match the recalled information should contact their pharmacist or prescribing healthcare provider for instructions and ask whether a replacement is needed. If the pharmacy transferred the tablets into a standard orange prescription bottle, the manufacturer’s lot number may not appear on the label. In that case, the pharmacy can help determine whether the prescription came from an affected batch.
The FDA did not issue a separate public news release for this recall; its enforcement report states that notifications were sent by letter. Patients and healthcare professionals can report suspected medication problems through the FDA’s MedWatch program or by calling 1-800-FDA-1088. With the recall still ongoing, checking the exact bottle details and consulting a healthcare professional remain the most important steps.