Naproxen Tablets — Class II drug recall D-0124-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2023-12-06, distributed nationwide. Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
| Recall number | D-0124-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2023-11-07 |
| Classified | 2023-11-27 |
| Reported by FDA | 2023-12-06 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| 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 | 19231858, 19231881, 19231903, 19233484, 19233490 |
| Expiration dates | 2025-04, 2025-08 |
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 for recall
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
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-0124-2024. 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.