# FDA recall D-0181-2016

> **Breckenridge Pharmaceutical, Inc** · Class III · drug recall initiated 2015-10-21.

## Product

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10

## Reason for recall

Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0181-2016
- **Recalling firm:** Breckenridge Pharmaceutical, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-21
- **Report date:** 2015-11-18
- **Termination date:** 2015-12-24

- **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-0181-2016

## Citation

> AI Analytics. FDA recall D-0181-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0181-2016. Source: US FDA. Licensed CC0.

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