US Drug Recall Register
Class III · Low risk Terminated Initiated Apr 29, 2021 (5 years ago)

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Presence of Foreign Tablet/Capsule

What was recalled

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

Recalling firm
Ascend Laboratories LLC
NDC code
67877-446-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0392-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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