# FDA recall D-0567-2025

> **Direct Rx** · Class II · drug recall initiated 2025-03-07.

## Product

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

## Reason for recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0567-2025
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-07
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0567-2025

## Citation

> AI Analytics. FDA recall D-0567-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0567-2025. Source: US FDA. Licensed CC0.

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