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Class II Recall
Ascend Laboratories, LLC
Product
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Reason
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Classification
Class II
Status
Ongoing
Lot
Lot: 24123460, Expires: October 31, 2027.
Date
2026-06-10
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.