# FDA recall D-500-2013

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2013-04-22.

## Product

Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for:  Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.  Made in India

## Reason for recall

Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..

## Distribution

Nationwide

## Key facts

- **Recall number:** D-500-2013
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-04-22
- **Report date:** 2013-06-05
- **Termination date:** 2014-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-500-2013

## Citation

> AI Analytics. FDA recall D-500-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-500-2013. Source: US FDA. Licensed CC0.

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