# FDA recall D-0595-2025

> **VIONA PHARMACEUTICALS INC** · Class II · drug recall initiated 2025-08-12.

## Product

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India.  Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016.  NDC:  72578-102-04

## Reason for recall

Discoloration

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0595-2025
- **Recalling firm:** VIONA PHARMACEUTICALS INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-12
- **Report date:** 2025-08-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0595-2025

## Citation

> AI Analytics. FDA recall D-0595-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0595-2025. Source: US FDA. Licensed CC0.

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