Thousands of bottles of blood pressure medication have been recalled nationwide after failing federal quality tests, according to the U.S. Food and Drug Administration (FDA). Macleods Pharma USA is recalling specific lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets.
The recall affects 3,528 30-count bottles from lot 12251163A and 216 90-count bottles from lot 12251163B. Both recalled lots expire on May 31, 2027.
Consumers can identify the recalled medications by checking their prescription bottles for the lot number and the National Drug Code (NDC). The 30-count bottles have NDC 33342-246-07, and the 90-count bottles have NDC 33342-246-10.
The FDA cited "failed dissolution specifications" as the reason for the recall, indicating that the pills did not dissolve as required during quality testing. This issue led the agency to classify the recall as a Class II recall, meaning the medication's use may cause temporary or medically reversible adverse health consequences, though the likelihood of serious health issues is considered remote.
Macleods Pharma USA initiated the recall on October 7, and the FDA classified it on October 26. The recall is ongoing and impacts products distributed across the United States.
This recall follows a similar action in September, when India-based Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets due to failed dissolution testing. Chlorthalidone is used to treat high blood pressure and fluid retention.
Macleods Pharma USA could not immediately be reached for comment.