NAPROXEN TABLETS USP — Class II drug recall D-1701-2012
Terminated recall by Glenmark Generics Inc., USA, reported 2012-10-03, distributed nationwide. Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravas
| Recall number | D-1701-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Generics Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2012-07-06 |
| Classified | 2012-09-27 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2015-08-13 |
| 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 | 02112930, 02112934, 02112941, 02112986, 02113334, 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, 09/14, 10/14, 11/14, 2112985 |
Product
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Reason for recall
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
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-1701-2012. 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.