FDA Classifies Nationwide Recall of Generic Blood Pressure Drug

A nationwide recall affecting 3,744 bottles of generic blood pressure medication could leave patients with less effective treatment, according to the US Food and Drug Administration (FDA). Macleods Pharmaceuticals initiated the recall on October 7, 2026, after the tablets failed dissolution specifications, raising concerns about how effectively the medicine releases its active ingredients.

The FDA classified the recall as Class II on October 26, 2026. This designation means the affected products could cause temporary or medically reversible health consequences, although serious health problems are considered unlikely.

According to the FDA's enforcement report, the recall covers 3,528 bottles containing 30 tablets and 216 bottles containing 90 tablets. The affected medication combines olmesartan medoxomil, amlodipine, and hydrochlorothiazide, three ingredients used in blood pressure treatment.

The recalled products have a strength of 40 mg/10 mg/12.5 mg and share an expiration date of May 31, 2027. Consumers can identify the affected packages using the following information:

30-count bottles: NDC 33342-246-07, lot number 12251163A.

90-count bottles: NDC 33342-246-10, lot number 12251163B.

The dissolution failure means the tablets may not release their active ingredients into the body at the expected rate. Consequently, the medication may not work as intended to control blood pressure.

The affected generic medication contains the same combination of active ingredients associated with the brand-name drug Tribenzor. However, the recall does not include brand-name Tribenzor itself.

Patients who use or previously used Tribenzor and are unsure whether they received a generic version should check their medication packaging against the recalled product information.

The FDA's Class II classification does not automatically require consumers to stop taking the medication. Under general guidance for this recall category, patients may continue using their medicine unless the manufacturer or FDA provides different instructions.

The FDA did not publish a separate news release announcing the recall. According to its enforcement report, notification letters were sent to businesses and individuals who might possess the affected medication.

Patients should consult their health care providers before changing or discontinuing their prescribed medication routine.