# FDA recall D-0484-2024

> **Breckenridge Pharmaceutical, Inc** · Class II · drug recall initiated 2024-04-29.

## Product

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

## Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0484-2024
- **Recalling firm:** Breckenridge Pharmaceutical, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-04-29
- **Report date:** 2024-05-15

- **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-0484-2024

## Citation

> AI Analytics. FDA recall D-0484-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0484-2024. Source: US FDA. Licensed CC0.

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