# FDA recall D-0235-2016

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class III · drug recall initiated 2015-11-02.

## Product

Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only.  Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for impurities.

## Distribution

US Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-0235-2016
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-11-02
- **Report date:** 2015-11-25
- **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-0235-2016

## Citation

> AI Analytics. FDA recall D-0235-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0235-2016. Source: US FDA. Licensed CC0.

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