# FDA recall D-0388-2025

> **Breckenridge Pharmaceutical, Inc** · Class II · drug recall initiated 2025-04-14.

## Product

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

## Reason for recall

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

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0388-2025
- **Recalling firm:** Breckenridge Pharmaceutical, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-14
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0388-2025

## Citation

> AI Analytics. FDA recall D-0388-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0388-2025. Source: US FDA. Licensed CC0.

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