Medications & Supplements/Prescription Drugs

Apotex Inc.: Metformin Extended-Release Tablets Recalled for NDMA Impurity

Agency Publication Date: June 12, 2020

Summary

Apotex Inc. has voluntarily recalled 305,963 bottles of Metformin Hydrochloride Extended-Release Tablets (500 mg) after FDA testing detected levels of N-Nitrosodimethylamine (NDMA) above acceptable intake limits. This prescription medication is used to control blood glucose in adults with type 2 diabetes. The recall affects 100-count bottles sold nationwide that are currently within their expiration date range. Consumers should consult their doctor before stopping this medication, as the risks of uncontrolled diabetes may outweigh the risks of the impurity.

Risk

NDMA is classified as a probable human carcinogen. Laboratory testing found that the levels of this impurity in the recalled tablets exceeded the safety thresholds established for daily intake, which may increase the risk of cancer with long-term exposure.

What You Should Do

Check your prescription bottle to see if it is Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, in a 100-count white bottle.
Look for NDC 60505-0260-1 on the bottle label and verify the manufacturer is listed as Apotex, Inc.
Verify if your bottle is part of the recall by checking that it is currently within its expiry date; the recall covers all lots that have not yet expired.
Contact your healthcare provider or pharmacist immediately to discuss your treatment options and obtain a replacement or alternative medication before you stop taking the recalled tablets.
Return any unused tablets to your pharmacy for a refund and contact Apotex Corp. at 1-800-706-5575 or by email at USCustomerService@Apotex.com for further instructions.
For additional information or to report a side effect, 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 healthcare provider and return to pharmacy

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 500 mg (100 count bottles)

Model:

NDC 60505-0260-1

Recall #: D-1303-2020

Lot Numbers:

All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85772

Status: Resolved

Manufacturer: Apotex Inc.

Sold By: Pharmacies

Manufactured In: Canada

Units Affected: 305,963 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

Check your prescription bottle to see if it is Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, in a 100-count white bottle.

Look for NDC 60505-0260-1 on the bottle label and verify the manufacturer is listed as Apotex, Inc.

Verify if your bottle is part of the recall by checking that it is currently within its expiry date; the recall covers all lots that have not yet expired.

Contact your healthcare provider or pharmacist immediately to discuss your treatment options and obtain a replacement or alternative medication before you stop taking the recalled tablets.

Return any unused tablets to your pharmacy for a refund and contact Apotex Corp. at 1-800-706-5575 or by email at USCustomerService@Apotex.com for further instructions.

For additional information or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.