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Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., ...

FDA Recall #D-0016-2026 — Class II — October 6, 2025

Recall #D-0016-2026 Date: October 6, 2025 Classification: Class II Status: Ongoing

Product Description

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

Recalling Firm

VIONA PHARMACEUTICALS INC — Cranford, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

13080 bottles

Distribution

USA Nationwide

Code Information

Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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