Naproxen Sodium Tablets — Class II drug recall D-0821-2021
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2021-09-29, distributed nationwide. CGMP Deviations
| Recall number | D-0821-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2021-08-27 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 9,552 bottles |
| Reason classes | cgmp |
| NDC | 68462-0178, 68462-0178-01, 68462-0178-05, 68462-0179, 68462-0179-01, 68462-0179-05, 68462-0188, 68462-0188-01, 68462-0188-05, 68462-0189, 68462-0189-01, 68462-0189-05, 68462-0190, 68462-0190-01, 68462-0190-05, 68462-0190-30, 68462-0190-50 |
| Lot numbers | 29190087, 29190088, 29190089, 29200077, 29200078 |
| Expiration dates | 2021-10-31, 2022-11-30 |
Product
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason for recall
CGMP Deviations
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-0821-2021. 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.