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Class II Recall
Ascend Laboratories, LLC
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
Failed Dissolution Specifications: low dissolution results
Classification
Class II
Status
Ongoing
Lot
Lot 23121560, Exp 4/30/2026
Date
2025-08-20
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.