# FDA recall D-1013-2019

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class II · drug recall initiated 2019-01-18.

## Product

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.  NDC:  51079-788-20

## Reason for recall

Failed Impurities/Degradation Specifications:  Elevated levels of a known impurity detected during 6-month RT stability interval.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-1013-2019
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-18
- **Report date:** 2019-03-27
- **Termination date:** 2020-04-29

- **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-1013-2019

## Citation

> AI Analytics. FDA recall D-1013-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1013-2019. Source: US FDA. Licensed CC0.

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