FDA Drug recall D-0643-2024
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…
- FDA Drug
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of 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… by Glenmark Pharmaceuticals Usa, citing failed Dissolution Specifications: below specification results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0643-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-31 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Failed Dissolution Specifications: below specification results
Identifiers
| ndc | 68462-325-60 |
|---|---|
| ndc | 68462-325-90 |
| ndc | 68462-325-01 |
| ndc | 68462-325-05 |
| ndc | 68462-325-10 |
| code_info | Lot#: 17240105, Exp 12/31/2025 |
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-0643-2024%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.