Home / Recalls / VIONA PHARMACEUTICALS INC / D-0016-2026

D-0016-2026 Class II Ongoing

Recalled by VIONA PHARMACEUTICALS INC — Cranford, NJ

Recall Details

Product Type
Drugs
Report Date
October 22, 2025
Initiation Date
October 6, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13080 bottles

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

Distribution Pattern

USA Nationwide

Code Information

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

Other recalls by VIONA PHARMACEUTICALS INC

  • D-0595-2025 Class II — Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use (August 12, 2025)
  • D-0172-2025 Class II — Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmed (December 10, 2024)
  • D-0171-2025 Class II — Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Aheme (December 10, 2024)
  • D-0038-2025 Class II — Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd (October 29, 2024)
  • D-0011-2025 Class II — Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd (September 24, 2024)
  • D-0392-2022 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bot (December 27, 2021)
  • D-0640-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx on (June 1, 2021)