Medications & Supplements/Prescription Drugs

Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Levels

Agency Publication Date: January 21, 2022

Summary

Viona Pharmaceuticals Inc. is recalling 238,416 bottles of Metformin Hydrochloride Extended-Release Tablets (USP 750 mg) in 100-count bottles. Testing detected N-Nitrosodimethylamine (NDMA) levels that exceed the Acceptable Daily Intake Limit. NDMA is classified as a probable human carcinogen. No injuries or adverse incidents have been reported in connection with this recall.

Risk

Long-term exposure to levels of NDMA above the acceptable daily limit may increase the risk of cancer. NDMA is a known environmental contaminant commonly found in water and certain foods.

What You Should Do

The recalled products are Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, sold in 100-count HDPE bottles with NDC number 72578-036-01.
Check the lot number and expiration date printed on the side of your medication bottle for any of the affected codes. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Viona Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (100 count)

Variants: 750 mg, Extended-Release Tablets, 100 count HDPE bottles

Lot Numbers:

M008130 (Exp 06/2022)

M008131 (Exp 06/2022)

M008132 (Exp 06/2022)

M008133 (Exp 06/2022)

M010080 (Exp 07/2022)

M010081 (Exp 07/2022)

M011029 (Exp 08/2022)

M011030 (Exp 08/2022)

M011031 (Exp 08/2022)

M011032 (Exp 08/2022)

M011304 (Exp 08/2022)

M013394 (Exp 09/2022)

M013395 (Exp 09/2022)

M013396 (Exp 09/2022)

M013966 (Exp 09/2022)

M013967 (Exp 09/2022)

M100831 (Exp 12/2022)

M100832 (Exp 12/2022)

M100833 (Exp 01/2023)

M100834 (Exp 01/2023)

M101267 (Exp 01/2023)

M102718 (Exp 01/2023)

M102719 (Exp 01/2023)

NDC:

72578-036-01

Recall Number D-0392-2022.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89305

Status: Resolved

Manufacturer: VIONA PHARMACEUTICALS INC

Sold By: wholesalers

Manufactured In: United States

Units Affected: 23,8416/100 count bottles

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

The recalled products are Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, sold in 100-count HDPE bottles with NDC number 72578-036-01.

Check the lot number and expiration date printed on the side of your medication bottle for any of the affected codes. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Viona Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (100 count)

Variants: 750 mg, Extended-Release Tablets, 100 count HDPE bottles

Lot Numbers:

M008130 (Exp 06/2022)

M008131 (Exp 06/2022)

M008132 (Exp 06/2022)

M008133 (Exp 06/2022)

M010080 (Exp 07/2022)

M010081 (Exp 07/2022)

M011029 (Exp 08/2022)

M011030 (Exp 08/2022)

M011031 (Exp 08/2022)

M011032 (Exp 08/2022)

M011304 (Exp 08/2022)

M013394 (Exp 09/2022)

M013395 (Exp 09/2022)

M013396 (Exp 09/2022)

M013966 (Exp 09/2022)

M013967 (Exp 09/2022)

M100831 (Exp 12/2022)

M100832 (Exp 12/2022)

M100833 (Exp 01/2023)

M100834 (Exp 01/2023)

M101267 (Exp 01/2023)

M102718 (Exp 01/2023)

M102719 (Exp 01/2023)

NDC:

72578-036-01

Recall Number D-0392-2022.