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Class II Recall
Ascend Laboratories, LLC
Product
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Reason
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Classification
Class II
Status
Ongoing
Lot
Lot 25121311, expiry 3/31/2028
Date
2026-07-29
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.