Naproxen Sodum Tablets USP 220 mg — Class II drug recall D-0777-2021
Terminated recall by Granules USA, Inc., reported 2021-09-08, distributed in NY. CGMP Deviations
| Recall number | D-0777-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules USA, Inc., Parsippany, NJ, United States |
| Recall initiated | 2021-08-11 |
| Classified | 2021-08-27 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2023-02-16 |
| Distributed | NY |
| Quantity | 11,450,000 tablets |
| Reason classes | cgmp |
| NDC | 62207-0762-36 |
Product
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36
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.