# FDA recall D-0643-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2024-07-31.

## 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

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0643-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-07-31
- **Report date:** 2024-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0643-2024

## Citation

> AI Analytics. FDA recall D-0643-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0643-2024. Source: US FDA. Licensed CC0.

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