# FDA recall D-0237-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-01-29.

## Product

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

## Reason for recall

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

## Distribution

Nationwide within the U.S

## Key facts

- **Recall number:** D-0237-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-01-29
- **Report date:** 2025-02-26

- **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-0237-2025

## Citation

> AI Analytics. FDA recall D-0237-2025. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0237-2025. Source: US FDA. Licensed CC0.

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