Nationwide Recall Issued for Blood Pressure Medication

The FDA has classified the recall as Class II, which means serious harm is considered unlikely.

A prescription combination drug used to treat high blood pressure is being pulled from the market nationwide after laboratory tests found the tablets were not breaking down properly.

Macleods Pharma USA, a New Jersey-based drug manufacturer, is recalling two lots of its Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets. According to the U.S. Food and Drug Administration, the recall stems from “failed dissolution specifications,” Fox Business reported. In other words, the tablets did not dissolve as expected during quality testing.

The action affects only those two lots, not every bottle of the medicine sold in the U.S. The FDA has categorized the recall as Class II, meaning the impacted products “may cause temporary or medically reversible adverse health consequences.” The agency says serious harm is unlikely.

Macleods began the recall on Oct. 7, and the FDA assigned its classification on Oct. 26. The recall is still active, and the affected bottles were distributed across the country.

A total of 3,744 bottles are included. That figure covers 3,528 bottles with 30 tablets each from lot 12251163A, plus 216 bottles with 90 tablets each from lot 12251163B. Both lots expire 31, 2027.

Patients can identify whether their medication is affected by checking the bottle label. In addition to the lot number, each bottle lists a National Drug Code, or NDC. The 30-tablet bottles carry NDC 33342-246-07, while the 90-tablet bottles carry NDC 33342-246-10.

Anyone who is unsure whether their medication is part of the recall should compare the lot number and NDC on the bottle with the details above. A pharmacist or doctor can confirm whether a bottle is included and advise on replacement options. In the meantime, patients should not stop taking blood pressure medication without medical guidance.