# FDA recall D-0257-2026

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2025-11-26.

## Product

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4

## Reason for recall

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0257-2026
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-26
- **Report date:** 2026-01-21

- **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-0257-2026

## Citation

> AI Analytics. FDA recall D-0257-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/D-0257-2026. Source: US FDA. Licensed CC0.

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