Recall D-0556-2026

US Class II Ongoing · initiated 2026-05-05

Recalling firm

Ascend Laboratories, LLC, NJ

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 for recall

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

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