Product: Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Reason for recall: Failed Dissolution Specifications: low dissolution results
Recall initiated: 20250721
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated