# FDA recall D-0107-2025

> **Rising Pharma Holding, Inc.** · Class II · drug recall initiated 2024-11-19.

## Product

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

## Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0107-2025
- **Recalling firm:** Rising Pharma Holding, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-19
- **Report date:** 2024-12-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0107-2025

## Citation

> AI Analytics. FDA recall D-0107-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0107-2025. Source: US FDA. Licensed CC0.

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