Medications & Supplements/Prescription Drugs

Marksans Pharma Limited: Metformin Extended-Release Tablets Recalled for NDMA Impurity

Agency Publication Date: June 25, 2020

Summary

Marksans Pharma Limited has recalled 11,279 bottles of Time-Cap Labs brand Metformin Hydrochloride Extended-Release (generic Glucophage) tablets, 500 mg. This prescription medication, used to manage blood sugar in patients with type 2 diabetes, was found during FDA testing to contain N-Nitrosodimethylamine (NDMA) at levels that exceed the acceptable daily intake limit. The affected product is sold in 100-count white plastic bottles and was distributed nationwide to pharmacies and distributors. Because stopping a diabetes medication suddenly can pose serious health risks, patients should continue taking their medication until they have spoken with a healthcare provider about a replacement.

Risk

NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above the safety limit may increase the risk of developing cancer. There are no reports of immediate illness or adverse events, but the chemical impurity was detected at levels higher than what the FDA considers safe for daily use.

What You Should Do

Check your prescription bottles to see if you have Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, from Time-Cap Labs, Inc.
Look for the National Drug Code (NDC) 49483-623-01 and Lot Number XP9004 with an expiration date of 12/2020 printed on the label.
Do NOT stop taking your medication immediately. It is dangerous for patients with type 2 diabetes to stop taking metformin without first consulting a doctor or pharmacist for an alternative treatment.
Contact your healthcare provider or pharmacist for guidance on how to obtain a replacement and for instructions on returning any unused product for a refund.
Contact Marksans Pharma Limited for more information regarding this recall.
For additional questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

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

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

Affected Products

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (100 Tablets)

Model:

NDC 49483-623-01

D-1356-2020

Lot Numbers:

XP9004 (exp 12/2020)

Date Ranges: December 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85818

Status: Resolved

Manufacturer: Marksans Pharma Limited

Sold By: Time-Cap Labs, Inc.

Manufactured In: India

Units Affected: 11279 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

Risk

What You Should Do

Check your prescription bottles to see if you have Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, from Time-Cap Labs, Inc.

Look for the National Drug Code (NDC) 49483-623-01 and Lot Number XP9004 with an expiration date of 12/2020 printed on the label.

Do NOT stop taking your medication immediately. It is dangerous for patients with type 2 diabetes to stop taking metformin without first consulting a doctor or pharmacist for an alternative treatment.

Contact your healthcare provider or pharmacist for guidance on how to obtain a replacement and for instructions on returning any unused product for a refund.

Contact Marksans Pharma Limited for more information regarding this recall.

For additional questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.