Medications & Supplements/Prescription Drugs

Direct Rx: Metformin HCL E/R 500 mg Recalled for NDMA Impurity Above Limits

Agency Publication Date: November 3, 2020

Summary

Direct Rx is recalling 88 bottles of Metformin HCL E/R (extended-release) 500 mg tablets, a prescription medication used to manage blood sugar in patients with type 2 diabetes. The recall was initiated because testing detected N-Nitrosodimethylamine (NDMA) at levels higher than the acceptable daily intake set by the manufacturer. NDMA is a substance that is classified as a probable human carcinogen. These affected bottles were distributed in Florida and packaged by Direct Rx in Dawsonville, Georgia.

Risk

The product contains the impurity NDMA at levels that exceed safety standards. Long-term exposure to NDMA above acceptable levels is linked to an increased risk of developing cancer.

What You Should Do

Check your medication bottle for Metformin HCL E/R 500 mg (90 Tablets) with NDC 72189-064-90.
Verify if your bottle matches lot numbers 04DE1902 or 11DE1908, both with an expiration date of 06/30/2021.
Continue taking your medication until you speak with your doctor or pharmacist. It can be dangerous for patients with type 2 diabetes to stop taking metformin without a replacement therapy.
Contact your healthcare provider or pharmacist immediately to discuss a replacement prescription or alternative treatment options.
Return any unused tablets from the affected lots to your pharmacy for a refund and contact Direct Rx for further instructions.
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

Full 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 HCL E/R 500 mg (90 Tabs)

Model:

NDC 72189-064-90

Lot Numbers:

04DE1902 (Exp. 06/30/2021)

11DE1908 (Exp. 06/30/2021)

Date Ranges: Expiration Date: 06/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86601

Status: Resolved

Manufacturer: Direct Rx

Sold By: Direct Rx

Manufactured In: United States

Units Affected: 88 bottles

Distributed To: Florida

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

Check your medication bottle for Metformin HCL E/R 500 mg (90 Tablets) with NDC 72189-064-90.

Verify if your bottle matches lot numbers 04DE1902 or 11DE1908, both with an expiration date of 06/30/2021.

Continue taking your medication until you speak with your doctor or pharmacist. It can be dangerous for patients with type 2 diabetes to stop taking metformin without a replacement therapy.

Contact your healthcare provider or pharmacist immediately to discuss a replacement prescription or alternative treatment options.

Return any unused tablets from the affected lots to your pharmacy for a refund and contact Direct Rx for further instructions.

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