VIONA PHARMACEUTICALS INC Recalls Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2021 1 2022 1 2024 2 2025 4
Download CSV FDA Recall
Ongoing
Historical record Class II
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. by VIONA PHARMACEUTICALS INC
Reason
Discoloration Published
October 22, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
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. NDC: 72578-102-04 by VIONA PHARMACEUTICALS INC
Reason
Discoloration Published
August 27, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
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 by VIONA PHARMACEUTICALS INC
Reason
Crystallization Published
January 8, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
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 by VIONA PHARMACEUTICALS INC
Reason
Crystallization Published
January 8, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
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. by VIONA PHARMACEUTICALS INC
Reason
Crystallization Published
November 13, 2024 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
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. by VIONA PHARMACEUTICALS INC
Reason
Crystallization Published
October 23, 2024 Distribution
NY
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FDA Recall
Terminated
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01 by VIONA PHARMACEUTICALS INC
Reason
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Published
February 2, 2022 Distribution
Product was distributed to 17 wholesaler…
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FDA Recall
Terminated
Historical record Class II
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 72578-036-01 by VIONA PHARMACEUTICALS INC
Reason
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Published
June 30, 2021 Distribution
Nationwide
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This page lists recalls that name VIONA PHARMACEUTICALS INC as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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