FDAClass IIOctober 22, 2025

Tavaborole Topical solution 5% recall

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.

Why was Tavaborole Topical solution 5% recalled?

Discoloration

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
VIONA PHARMACEUTICALS INC
Quantity
13080 bottles
Distribution
USA Nationwide
Recall date
October 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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