# FDA recall D-0163-2025

> **PD-Rx Pharmaceuticals, Inc.** · Class II · drug recall initiated 2024-12-04.

## Product

DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

## Reason for recall

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

## Distribution

Distributed within US: FL, MS, WI

## Key facts

- **Recall number:** D-0163-2025
- **Recalling firm:** PD-Rx Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-12-04
- **Report date:** 2025-01-01
- **Termination date:** 2025-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oklahoma City, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2025

## Citation

> AI Analytics. FDA recall D-0163-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0163-2025. Source: US FDA. Licensed CC0.

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