FDA Drug recall D-0346-2025
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prade…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prade… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0346-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-13 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
Reason
CGMP Deviations
Identifiers
| ndc | 68462-188-01 |
|---|---|
| ndc | 68462-188-05 |
| ndc | 68462-189-01 |
| ndc | 68462-189-05 |
| ndc | 68462-190-30 |
| ndc | 68462-190-50 |
| ndc | 68462-190-01 |
| ndc | 68462-190-05 |
| ndc | 68462-178-01 |
| ndc | 68462-178-05 |
| ndc | 68462-179-01 |
| ndc | 68462-179-05 |
| code_info | Lot # 17231956, exp. date Aug-25 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0346-2025%22
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