FDA Recall D-0016-2026

VIONA PHARMACEUTICALS INC · Cranford, NJ

Class II Ongoing 220 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

Quantity: 13080 bottles

Reason for recall

Discoloration

Recall record

Recall number: D-0016-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-10-06
Classified by FDA Center: 2025-10-10
FDA published: 2025-10-22
Recalling firm: VIONA PHARMACEUTICALS INC
Firm location: Cranford, NJ

Drug identification

Brand name(s): TAVABOROLE
Generic name(s): TAVABOROLE
Manufacturer(s): Viona Pharmaceuticals Inc
NDC(s): 72578-102
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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