More than 3,700 bottles of prescription blood pressure medication have been recalled across the United States after the tablets failed a test that determines how properly they release their active ingredients. The affected drug is a generic version of Tribenzor, a treatment prescribed to patients with high blood pressure.
Why the FDA Classified the Recall as Class II
According to the U.S. Food and Drug Administration (FDA), Macleods Pharmaceuticals initiated the voluntary recall on October 7, 2026, after certain tablets failed to meet established dissolution specifications. The agency officially classified the action as a Class II recall on October 26.
Dissolution testing measures how a tablet releases its active pharmaceutical ingredients under specified conditions. When a medication fails these requirements, its ingredients may not become available at the intended rate, potentially affecting how well the treatment works.
For patients managing hypertension, this raises concerns about whether the affected tablets can consistently lower blood pressure as prescribed.
A Class II designation indicates that exposure to the recalled product may cause temporary or medically reversible adverse health consequences. The FDA also considers the probability of serious adverse health consequences to be remote.
The classification does not mean every affected tablet has failed to control blood pressure or that patients taking the medication have experienced harm.
Which Blood Pressure Tablets Are Affected?
The recall involves olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, a combination medication containing three ingredients that lower blood pressure through different mechanisms.
The affected tablets contain 40 mg of olmesartan medoxomil, 10 mg of amlodipine, and 12.5 mg of hydrochlorothiazide.
Macleods Pharmaceuticals identified two specific lots distributed in different bottle sizes.
| Bottle Size | NDC Number | Lot Number |
|---|---|---|
| 30 tablets | 33342-246-07 | 12251163A |
| 90 tablets | 33342-246-10 | 12251163B |
Both lots carry an expiration date of May 31, 2027.
The recall covers 3,528 bottles containing 30 tablets and 216 bottles containing 90 tablets, bringing the total to 3,744 bottles, or 125,280 tablets.
Patients should compare the National Drug Code (NDC), lot number, and expiration date printed on their medication packaging with the recalled products.
Is Brand-Name Tribenzor Also Recalled?
Although the affected medication contains the same combination of active ingredients found in Tribenzor, the recall does not include the brand-name product.
The distinction matters because pharmacies frequently dispense generic versions of prescription medications. Patients familiar with the Tribenzor name may be taking a generic equivalent without recognizing the manufacturer’s name.
Only the identified Macleods Pharmaceuticals lots are covered by this recall. Other strengths, manufacturers, and batches are not identified as affected in the reported recall.
What Patients Should Do If They Have the Recalled Medication
Patients who discover a matching bottle should contact their pharmacist or healthcare provider before making changes to their prescribed treatment.
Stopping blood pressure medication without medical guidance can leave hypertension uncontrolled, increasing the risk of complications such as stroke and heart disease.
The FDA’s Class II classification does not automatically require patients to stop taking a recalled medication immediately. Any decision to discontinue treatment or switch prescriptions should follow guidance from a qualified healthcare professional.
Patients can also ask their pharmacy to verify the manufacturer and lot number if the information is difficult to locate on the dispensing label.
The FDA did not publish a separate news release announcing this recall. Instead, its enforcement report indicates that notification letters were sent to affected businesses and individuals as part of the recall process.
