Medications & Supplements/Prescription Drugs

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

Agency Publication Date: May 17, 2021

Summary

Preferred Pharmaceuticals, Inc. has voluntarily recalled 147 bottles (14,700 tablets) of Metformin HCl Extended Release Tablets USP 500 mg, a generic version of Glucophage XR. This prescription medication is being recalled because testing detected levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit. These tablets were manufactured by Time-Cap Labs Inc. and distributed to two physician locations in Florida in bottles of 100 tablets each.

Risk

NDMA is classified as a probable human carcinogen; long-term exposure to levels above the acceptable daily limit may increase the risk of cancer.

What You Should Do

Check your prescription bottle for 'Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg' (Generic for Glucophage XR) with NDC number 68788-6932-1.
Identify if your bottle belongs to any of the following four affected lots: C2520W (Exp. 12/31/2021), E0620F (Exp. 12/31/2021), G2020M (Exp. 4/30/2022), or G2720A (Exp. 4/30/2022).
Contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment before you stop taking this medication, as it is dangerous for patients with type 2 diabetes to stop taking metformin without medical advice.
Return any unused product from the affected lots to your pharmacy or place of purchase to receive a refund.
Contact Preferred Pharmaceuticals, Inc. at their Anaheim, California location for further instructions regarding this recall.
For additional questions or to report adverse effects, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare 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: Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg (100-count bottle)

Model:

NDC 68788-6932-1

Lot Numbers:

C2520W (Exp. 12/31/2021)

E0620F (Exp. 12/31/2021)

G2020M (Exp. 4/30/2022)

G2720A (Exp. 4/30/2022)

Date Ranges: Expiration 12/31/2021, Expiration 4/30/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87833

Status: Active

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: Physician consignees

Manufactured In: United States

Units Affected: 147 bottles (14,700 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 prescription bottle for 'Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg' (Generic for Glucophage XR) with NDC number 68788-6932-1.

Identify if your bottle belongs to any of the following four affected lots: C2520W (Exp. 12/31/2021), E0620F (Exp. 12/31/2021), G2020M (Exp. 4/30/2022), or G2720A (Exp. 4/30/2022).

Contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment before you stop taking this medication, as it is dangerous for patients with type 2 diabetes to stop taking metformin without medical advice.

Return any unused product from the affected lots to your pharmacy or place of purchase to receive a refund.

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

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