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

Recall Number: D-0712-2026

Firm: Ascend Laboratories, LLC

Classification: Class II

Status: Ongoing

Report Date: 20260729

Initiation Date: 20260708

Termination Date:

Reason for Recall

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Product Description

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

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Data source: openFDA · Updated regularly