Cranford, NJ, United States
VIONA PHARMACEUTICALS INC recalls
7 recalls recorded since 2018, most recently on 6 October 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)5
Terminated or completed2
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 6 October 2025
- Reason
- Discoloration
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0016-2026
- 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.
Ongoing Class II Drugs
- Recall started
- 12 August 2025
- Reason
- Discoloration
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0595-2025
- Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016
Ongoing Class II Drugs
- Recall started
- 10 December 2024
- Reason
- Crystallization
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0172-2025, D-0171-2025
- Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
- Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Ongoing Class II Drugs
- Recall started
- 29 October 2024
- Reason
- Crystallization
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0038-2025
- Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Ongoing Class II Drugs
- Recall started
- 24 September 2024
- Reason
- Crystallization
- Distribution
- NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0011-2025
- Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Terminated Class II Drugs
- Recall started
- 27 December 2021
- Terminated
- 20 September 2023
- Reason
- CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Distribution
- Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0392-2022
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Terminated Class II Drugs
- Recall started
- 1 June 2021
- Terminated
- 31 May 2023
- Reason
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0640-2021
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-0
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.