# FDA recall D-0308-2025

> **Breckenridge Pharmaceutical, Inc.** · Class II · drug recall initiated 2025-03-26.

## Product

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

## Reason for recall

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0308-2025
- **Recalling firm:** Breckenridge Pharmaceutical, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-26
- **Report date:** 2025-04-09

- **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-0308-2025

## Citation

> AI Analytics. FDA recall D-0308-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0308-2025. Source: US FDA. Licensed CC0.

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