# FDA recall D-0342-2026

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2026-01-27.

## Product

Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7

## Reason for recall

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0342-2026
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-01-27
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0342-2026

## Citation

> AI Analytics. FDA recall D-0342-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0342-2026. Source: US FDA. Licensed CC0.

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