# FDA recall D-1095-2014

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2014-01-24.

## Product

Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.

## Reason for recall

CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1095-2014
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-24
- **Report date:** 2014-03-12
- **Termination date:** 2014-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1095-2014

## Citation

> AI Analytics. FDA recall D-1095-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1095-2014. Source: US FDA. Licensed CC0.

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