# FDA recall D-0100-2026

> **Breckenridge Pharmaceutical, Inc.** · Class II · drug recall initiated 2025-10-09.

## Product

Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC  51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.

## Reason for recall

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0100-2026
- **Recalling firm:** Breckenridge Pharmaceutical, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-09
- **Report date:** 2025-11-05

- **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-0100-2026

## Citation

> AI Analytics. FDA recall D-0100-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0100-2026. Source: US FDA. Licensed CC0.

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