# FDA recall D-0256-2026

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2025-12-30.

## Product

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

## Distribution

Nationwide within the USA

## Key facts

- **Recall number:** D-0256-2026
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-12-30
- **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-0256-2026

## Citation

> AI Analytics. FDA recall D-0256-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0256-2026. Source: US FDA. Licensed CC0.

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