# FDA recall D-1239-2015

> **Qualitest Pharmaceuticals** · Class III · drug recall initiated 2015-06-29.

## Product

HydrOXYzine Hydrochloride Tablets, USP 25 mg,  Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

## Reason for recall

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1239-2015
- **Recalling firm:** Qualitest Pharmaceuticals
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-06-29
- **Report date:** 2015-07-22
- **Termination date:** 2016-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Huntsville, AL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1239-2015

## Citation

> AI Analytics. FDA recall D-1239-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1239-2015. Source: US FDA. Licensed CC0.

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