Naproxen Sodium Tablets — Class II drug recall D-0822-2021
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2021-09-29, distributed nationwide. CGMP Deviations
| Recall number | D-0822-2021 |
|---|---|
| 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) |
| 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 |
| Expiration dates | 2021-09-30, 2021-10-31, 2021-12-31, 2022-01-31, 2022-02-28 |
Product
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Reason for recall
CGMP Deviations
Machine access
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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.