FDA Drug recall D-0124-2024
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd
- FDA Drug
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd by Glenmark Pharmaceuticals Usa, citing labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0124-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-07 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
Reason
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
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# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class III · 2025-12-17 · Glenmark Pharmaceuticals Usa - Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30
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All Glenmark Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0124-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.