# FDA recall D-0216-2026

> **Breckenridge Pharmaceutical, Inc.** · Class II · drug recall initiated 2025-11-24.

## Product

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

## Reason for recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0216-2026
- **Recalling firm:** Breckenridge Pharmaceutical, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-24
- **Report date:** 2025-12-10

- **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-0216-2026

## Citation

> AI Analytics. FDA recall D-0216-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0216-2026. Source: US FDA. Licensed CC0.

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