# FDA recall D-0016-2026

> **VIONA PHARMACEUTICALS INC** · Class II · drug recall initiated 2025-10-06.

## Product

Tavaborole Topical solution 5%, 10 mL bottle, Rx 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

USA Nationwide

## Key facts

- **Recall number:** D-0016-2026
- **Recalling firm:** VIONA PHARMACEUTICALS INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-06
- **Report date:** 2025-10-22

- **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-0016-2026

## Citation

> AI Analytics. FDA recall D-0016-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0016-2026. Source: US FDA. Licensed CC0.

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