FDA Drug · D-0712-2026

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

Class II · Ongoing

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Affected lots / codes — check yours against thisLot 25121311, expiry 3/31/2028

Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 6,192 bottles
Distribution: Nationwide in the USA
Recall initiated: July 8, 2026
Classified: July 20, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0712-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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