Olmesartan Medoxomil Tablets 20 mg — Class II drug recall D-0828-2020
Terminated recall by Ascend Laboratories LLC, reported 2020-02-12, distributed nationwide. cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to f
| Recall number | D-0828-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2020-01-24 |
| Classified | 2020-02-06 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 192 bottles |
| Reason classes | cgmp |
| NDC | 67877-0445, 67877-0445-05, 67877-0445-10, 67877-0445-30, 67877-0445-90, 67877-0446, 67877-0446-05, 67877-0446-10, 67877-0446-30, 67877-0446-33, 67877-0446-38, 67877-0446-74, 67877-0446-84, 67877-0446-90, 67877-0447, 67877-0447-05, 67877-0447-10, 67877-0447-30, 67877-0447-90 |
| Lot numbers | 19122552 |
| Expiration dates | 2021-07-31 |
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 for recall
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0828-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.