# FDA recall D-0123-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2023-11-07.

## Product

Indomethacin 25mg Capsules, USP, 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 68462-406-01

## Reason for recall

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0123-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-11-07
- **Report date:** 2023-12-06

- **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-0123-2024

## Citation

> AI Analytics. FDA recall D-0123-2024. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0123-2024. Source: US FDA. Licensed CC0.

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