# FDA recall D-0116-2017

> **Taro Pharmaceuticals, Inc.** · Class II · drug recall initiated 2016-09-13.

## Product

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

## Reason for recall

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

## Distribution

US & Puerto Rico

## Key facts

- **Recall number:** D-0116-2017
- **Recalling firm:** Taro Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-13
- **Report date:** 2016-11-09
- **Termination date:** 2018-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brampton, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0116-2017

## Citation

> AI Analytics. FDA recall D-0116-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0116-2017. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
