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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

VIONA PHARMACEUTICALS INC: Metformin ER Tablets Recalled for Excessive NDMA Levels

Agency Publication Date: June 24, 2021
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Summary

Viona Pharmaceuticals Inc. has recalled 21,240 bottles of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, which is a prescription medication used to control blood sugar in patients with type 2 diabetes. The recall was initiated because testing detected levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit. While NDMA is a common environmental contaminant, long-term exposure to levels above the safety limit may increase the risk of cancer. This recall affects specific 100-count bottles manufactured by Cadila Healthcare Ltd. and distributed nationwide.

Risk

The tablets contain N-Nitrosodimethylamine (NDMA) at levels higher than the FDA's Acceptable Daily Intake Limit. NDMA is classified as a probable human carcinogen, meaning long-term exposure above safety thresholds could potentially increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle to see if it is Metformin Hydrochloride Extended-Release Tablets, USP 750 mg in 100-count bottles.
  2. Locate the NDC number 72578-036-01 and look for Lot numbers M915601 or M915602 with an expiration date of Oct 2021 printed on the label.
  3. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for medical advice and to obtain a replacement prescription before you stop taking your current medication.
  4. It is dangerous for patients with type 2 diabetes to stop taking metformin without first consulting a doctor or having an alternative treatment ready.
  5. Return any unused portions of the affected lots to your pharmacy for a refund and contact Viona Pharmaceuticals Inc. for further instructions regarding the return process.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and medical guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (100-count bottle)
Model:
NDC 72578-036-01
Recall #: D-0640-2021
Lot Numbers:
M915601 (Exp Oct 2021)
M915602 (Exp Oct 2021)
Date Ranges: Oct 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88033
Status: Resolved
Manufacturer: VIONA PHARMACEUTICALS INC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 21240 bottles
Distributed To: Nationwide
Agency Last Updated: July 7, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.