# FDA recall D-0165-2025

> **RemedyRepack Inc.** · Class II · drug recall initiated 2024-12-02.

## Product

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

## Reason for recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0165-2025
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-02
- **Report date:** 2025-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2025

## Citation

> AI Analytics. FDA recall D-0165-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0165-2025. Source: US FDA. Licensed CC0.

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