FDA Drug recall D-0392-2021
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013
- FDA Drug
- Class III
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class III recall of Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013 by Ascend Laboratories, citing presence of Foreign Tablet/Capsule.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0392-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-04-29 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
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.
Reason
Presence of Foreign Tablet/Capsule
Identifiers
| ndc | 67877-445-30 |
|---|---|
| ndc | 67877-445-90 |
| ndc | 67877-445-05 |
| ndc | 67877-445-10 |
| ndc | 67877-446-30 |
| ndc | 67877-446-90 |
| ndc | 67877-446-05 |
| ndc | 67877-446-10 |
| ndc | 67877-446-33 |
| ndc | 67877-446-84 |
| ndc | 67877-446-74 |
| ndc | 67877-446-38 |
| ndc | 67877-447-30 |
| ndc | 67877-447-90 |
| ndc | 67877-447-05 |
| ndc | 67877-447-10 |
| code_info | Batch No. 20122548, Exp Date: Aug. 2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0392-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.