# FDA recall D-0650-2016

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class III · drug recall initiated 2016-01-28.

## Product

Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21

## Reason for recall

Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0650-2016
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-28
- **Report date:** 2016-02-10
- **Termination date:** 2016-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0650-2016

## Citation

> AI Analytics. FDA recall D-0650-2016. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0650-2016. Source: US FDA. Licensed CC0.

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