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.

Recall Number: D-0556-2026

Firm: Ascend Laboratories, LLC

Classification: Class II

Status: Ongoing

Report Date: 20260610

Initiation Date: 20260505

Termination Date:

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

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.