Recall Atlas
Drugs & medicalClass II

VIONA PHARMACEUTICALS INC recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Read the official notice →
Date
2022-02-02
Country
United States
Brand
Viona Pharmaceuticals
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Classification
Class II
Units
Product was distributed to 17 wholesalers who further distributed the product…
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Viona Pharmaceuticals recalls

  1. 2025-10-22
  2. US
    Drugs & medicalClass II

    VIONA PHARMACEUTICALS INC recalls Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India,…

    Discoloration

    FDA · DrugVIONA PHARMACEUTICALS INCUSA NationwideOfficial notice →
  3. 2025-08-27
  4. US
    Drugs & medicalClass II

    VIONA PHARMACEUTICALS INC recalls Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd.,…

    Discoloration

    FDA · DrugVIONA PHARMACEUTICALS INCNationwide in the USAOfficial notice →
  5. 2025-01-08
  6. US
    Drugs & medicalClass II

    VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals…

    Crystallization

    FDA · DrugVIONA PHARMACEUTICALS INCUS NationwideOfficial notice →
  7. 2024-11-13
  8. US
    Drugs & medicalClass II

    VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona…

    Crystallization

    FDA · DrugVIONA PHARMACEUTICALS INCUSA NationwideOfficial notice →
  9. 2024-10-23
  10. US
    Drugs & medicalClass II

    VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona…

    Crystallization

    FDA · DrugVIONA PHARMACEUTICALS INCNYOfficial notice →
All 6 Viona Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2022-02-02
  2. US
    Drugs & medicalClass II

    Edge Pharma, LLC recalls Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge…

    Lack of Assurance of Sterility

    FDA · DrugEdge Pharma, LLCnationwideOfficial notice →
  3. US
    Drugs & medicalClass II

    Edge Pharma, LLC recalls Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge…

    Lack of Assurance of Sterility.

    FDA · DrugEdge Pharma, LLCnationwideOfficial notice →
  4. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd.,…

    Failed Dissolution Specifications.

    FDA · DrugAscend Laboratories, LLCNationwide in the USAOfficial notice →
  5. 2022-01-26
  6. US
    Drugs & medicalClass II

    Covidien, LP recalls SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

    Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable…

    FDA · DeviceCovidien, LPThe devices were distributed to the following US states: CA, CO, FL, IL, KY,…Official notice →
  7. US
    Drugs & medicalClass II

    Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

    Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm…

    FDA · DeviceStraumann USA LLCUS Nationwide Distribution in the states of FL, IL, OHOfficial notice →
  8. US
    Drugs & medicalClass II

    Microbiologics Inc recalls KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC…

    Contamination with S. epidermidis

    FDA · DeviceMicrobiologics IncDistribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and…Official notice →
See all drugs & medical recalls →