Indomethacin Extended-Release Capsules — Class II drug recall D-0643-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-09-04, distributed nationwide. Failed Dissolution Specifications: below specification results
| Recall number | D-0643-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-07-31 |
| Classified | 2024-08-23 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 2,404 bottles |
| Reason classes | specification failure |
| NDC | 68462-0325, 68462-0325-01, 68462-0325-05, 68462-0325-10, 68462-0325-60, 68462-0325-90 |
| Lot numbers | 17240105 |
| Expiration dates | 2025-12-31 |
Product
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Reason for recall
Failed Dissolution Specifications: below specification results
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-0643-2024. 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.