# FDA recall D-0212-2025

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class II · drug recall initiated 2025-01-13.

## Product

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.

## Reason for recall

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0212-2025
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2025-01-13
- **Report date:** 2025-02-05
- **Termination date:** 2026-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Vergne, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0212-2025

## Citation

> AI Analytics. FDA recall D-0212-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0212-2025. Source: US FDA. Licensed CC0.

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