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Thousands of bottles of blood pressure medication have been recalled across the United States after the pills failed to meet federal quality standards, according to the U.S. Food and Drug Administration (FDA). Macleods Pharma USA, a New Jersey-based pharmaceutical company, is recalling certain lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets following failed dissolution tests, which means the pills did not dissolve as required during testing.
The recall affects 3,528 30-count bottles from lot 12251163A and 216 90-count bottles from lot 12251163B. Both lots expire on May 31, 2027. The FDA issued a Class II recall rating after Macleods Pharma USA initiated the recall. As explained by the FDA, a Class II recall is used when use of the affected medication “may cause temporary or medically reversible adverse health consequences,” but the chance of serious outcomes is considered remote.
Consumers are urged to check their prescription bottles for the affected lot numbers and National Drug Codes (NDC): the recalled 30-count bottles have NDC 33342-246-07, and the 90-count bottles have NDC 33342-246-10. Patients taking these medications should contact their pharmacists or health care providers for guidance. The FDA emphasized that failure to address the recall could pose risks from unmanaged high blood pressure.