# FDA recall D-0511-2025

> **Breckenridge Pharmaceutical, Inc.** · Class II · drug recall initiated 2025-06-30.

## Product

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only,   Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

## Reason for recall

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

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0511-2025
- **Recalling firm:** Breckenridge Pharmaceutical, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-30
- **Report date:** 2025-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berkeley Heights, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2025

## Citation

> AI Analytics. FDA recall D-0511-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0511-2025. Source: US FDA. Licensed CC0.

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