# FDA recall D-0522-2026

> **Breckenridge Pharmaceutical, Inc.** · Class II · drug recall initiated 2026-04-21.

## Product

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count  bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0522-2026
- **Recalling firm:** Breckenridge Pharmaceutical, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-21
- **Report date:** 2026-05-13

- **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-0522-2026

## Citation

> AI Analytics. FDA recall D-0522-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0522-2026. Source: US FDA. Licensed CC0.

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