FDA Drug recall D-0828-2020
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distr…
- FDA Drug
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distr… by Ascend Laboratories, citing cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0828-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-24 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Reason
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
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 | Lot #: 19122552, Exp 7/31/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Ascend Laboratories
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laborator…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratori…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2026-07-29 · Ascend Laboratories - Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…
FDA Drug · Class III · 2026-07-29 · Ascend Laboratories
All Ascend Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0828-2020%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.