Medications & Supplements/Prescription Drugs

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

Agency Publication Date: November 14, 2020

Summary

Preferred Pharmaceuticals, Inc. has recalled 99 bottles (totaling 9,990 tablets) of Metformin HCl Extended Release Tablets USP 500 mg, which is the generic version of Glucophage XR. This recall was initiated after FDA analysis discovered levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit. The affected medication was manufactured by Time-Cap Labs, Inc. and distributed to two physician's offices in Florida.

Risk

NDMA is classified as a probable human carcinogen. Exposure to levels above the recommended daily limit over a long period of time may increase the risk of cancer.

What You Should Do

Check your medication bottle to see if you have Metformin HCl Extended Release Tablets USP 500 mg with NDC number 68788-6932-1.
Identify if your bottle belongs to affected lot E0620F (Expiration 12/31/2021) or lot G2020M (Expiration 04/30/2022).
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication, as it is dangerous for patients with type 2 diabetes to stop taking metformin without a replacement therapy.
Return any unused or affected product to your pharmacy or the physician's office where it was received to obtain a refund.
Contact Preferred Pharmaceuticals, Inc. at their California headquarters for further instructions regarding this recall.
For additional questions or to report adverse effects, 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

Healthcare provider consultation and pharmacy 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 68788-6932-1

Recall #: D-0077-2021

Lot Numbers:

E0620F (Exp. 12/31/2021)

G2020M (Exp. 04/30/2022)

Date Ranges: Expiration 12/31/2021, Expiration 04/30/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86696

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: physician's offices

Manufactured In: United States

Units Affected: 99 bottles (9990 Extended Release Tablets)

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 to see if you have Metformin HCl Extended Release Tablets USP 500 mg with NDC number 68788-6932-1.

Identify if your bottle belongs to affected lot E0620F (Expiration 12/31/2021) or lot G2020M (Expiration 04/30/2022).

Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication, as it is dangerous for patients with type 2 diabetes to stop taking metformin without a replacement therapy.

Return any unused or affected product to your pharmacy or the physician's office where it was received to obtain a refund.

Contact Preferred Pharmaceuticals, Inc. at their California headquarters for further instructions regarding this recall.

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