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FDARecalled Jul 29, 2026 · #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...

Hazard

Class II — temporary health risk

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Description

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications Classification: Class II Distribution: Nationwide in the USA

Product details

Product
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
Type
Drugs
Manufacturer
Ascend Laboratories, LLC
Model numbers
25121311
UPCs