Medications & Supplements/Prescription Drugs

Preferred Pharmaceuticals, Inc.: Metformin Extended Release Tablets Recalled for Excessive NDMA Levels

Agency Publication Date: June 26, 2020

Summary

Preferred Pharmaceuticals, Inc. has recalled 144 bottles of Metformin HCl Extended Release Tablets (500 mg), a generic version of Glucophage XR. This recall was initiated because FDA testing found levels of N-Nitrosodimethylamine (NDMA) that exceed acceptable daily intake limits. NDMA is a substance that could increase the risk of cancer if people are exposed to it above acceptable levels over long periods of time. The affected 100-count bottles were distributed to two medical clinics in Florida.

Risk

The tablets contain NDMA levels that exceed the FDA's Acceptable Daily Intake Limit. 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.

What You Should Do

Check your medication bottle for Metformin HCl Extended Release Tablets, USP, 500 mg (generic for Glucophage XR) in 100-count packages with NDC 68788-6932-01.
Verify if your bottle matches one of the following lot numbers: J0119M, K1419L, K2719J, or A0220H, all with an expiration date of 12/2020.
Contact your healthcare provider or pharmacist immediately for guidance on your treatment. It is dangerous to stop taking prescription metformin without a replacement, as it controls blood sugar levels.
Return any unused or remaining medication from these specific lots to the medical clinic or pharmacy where you received it for a refund.
Contact Preferred Pharmaceuticals at their Anaheim, CA office or the FDA at 1-888-723-3332 (1-888-SAFEFDA) for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

Full Refund

Healthcare consultation and product return for refund.

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 Extended Release Tablets, USP, 500 mg (100-count bottle)

Model:

NDC: 68788-6932-01

Recall #: D-1364-2020

Lot Numbers:

J0119M (Exp. 12/2020)

K1419L (Exp. 12/2020)

K2719J (Exp. 12/2020)

A0220H (Exp. 12/2020)

Date Ranges: December 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85880

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: Medical clinics

Manufactured In: United States

Units Affected: 144 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 Extended Release Tablets, USP, 500 mg (generic for Glucophage XR) in 100-count packages with NDC 68788-6932-01.

Verify if your bottle matches one of the following lot numbers: J0119M, K1419L, K2719J, or A0220H, all with an expiration date of 12/2020.

Contact your healthcare provider or pharmacist immediately for guidance on your treatment. It is dangerous to stop taking prescription metformin without a replacement, as it controls blood sugar levels.

Return any unused or remaining medication from these specific lots to the medical clinic or pharmacy where you received it for a refund.

Contact Preferred Pharmaceuticals at their Anaheim, CA office or the FDA at 1-888-723-3332 (1-888-SAFEFDA) for further instructions.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.