Recall Register

VIONA PHARMACEUTICALS INC: FDA recalls

FDA enforcement reports name VIONA PHARMACEUTICALS INC as the recalling firm in 7 events. The events have 8 product records. The recalls started from 2021 to 2025. All the events are drug recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

7 events, newest first.

FDA enforcement events of VIONA PHARMACEUTICALS INC
InitiatedProduct (first record)TypeClassRecordsStatus
6 Oct 2025Tavaborole 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.DrugClass II1Ongoing
12 Aug 2025Tavaborole 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: 72578-102-04DrugClass II1Ongoing
10 Dec 2024Dapsone 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 packDrugClass II2Ongoing
29 Oct 2024Dapsone 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.DrugClass II1Ongoing
24 Sep 2024Dapsone 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.DrugClass II1Ongoing
27 Dec 2021Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01DrugClass II1Terminated
1 Jun 2021Metformin 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 72578-036-01DrugClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

VIONA PHARMACEUTICALS INC: events for each product type
TypeEvents
Drug7
VIONA PHARMACEUTICALS INC: events in each class
ClassEvents
Class II7
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of VIONA PHARMACEUTICALS INC, by the year that the recall started. The largest year is 2024, with 3 events.

Official channels

Cite this page

Recall Register. VIONA PHARMACEUTICALS INC: FDA recalls. https://recallregister.com/firm/viona-pharmaceuticals-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of VIONA PHARMACEUTICALS INC have?
Class II: 7 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of VIONA PHARMACEUTICALS INC?
FDA event 97756, which the firm started on 6 Oct 2025. The first product in the record is: 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.
How many FDA recalls of VIONA PHARMACEUTICALS INC have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.