Medications & Supplements/Prescription Drugs

PD-Rx Pharmaceuticals, Inc.: Metformin HCL ER Recalled Due to Excessive Levels of NDMA Impurity

Agency Publication Date: November 3, 2020

Summary

Approximately 1,808 bottles of Metformin HCL ER (extended-release) in 500 mg and 750 mg strengths have been recalled. This medication, used to manage blood sugar in adults with type 2 diabetes, was found to contain N-Nitrosodimethylamine (NDMA) at levels that exceed the daily intake limit set by the FDA. The recall affects various bottle sizes ranging from 30 to 180 tablets that were distributed to pharmacies and healthcare providers in 16 states. Consumers should be aware that the manufacturer initiated this recall voluntarily following the detection of these impurities during testing.

Risk

NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above acceptable limits may increase the risk of developing cancer. While no immediate illnesses or injuries have been reported, the presence of this impurity violates safety standards and requires medical consultation to manage potential long-term health risks.

What You Should Do

Check your prescription bottle label for the name 'metformin HCL ER' and the strengths 500 mg or 750 mg.
Verify if your bottle matches one of the following NDC numbers: 72789-009-30, 72789-009-60, 72789-009-90, 72789-009-93 (for 500 mg) or 43063-902-30, 43063-902-60 (for 750 mg).
Check for affected 500 mg lots including B20D23, B20D67 (Exp. 07/31/21), C20D55 (Exp. 12/31/21), A20D92, A20F59, B20C16 (Exp. 07/31/21), C20D63, D20A45, D20C80 (Exp. 12/31/21), G20D46, and I20C57 (Exp. 04/30/22).
Check for affected 750 mg lots including A20A97, B20D25 (Exp. 04/30/21), B20D69, C20B95, C20D60, E20A50 (Exp. 07/31/21), E20D37, E20D73 (Exp. 03/31/22), J19F04 (Exp. 01/31/21), C20C15 (Exp. 07/31/21), F20A14 (Exp. 03/31/22), and L19C15 (Exp. 04/30/21).
Do NOT stop taking your medication before talking to your doctor or pharmacist. Abruptly stopping metformin treatment for type 2 diabetes can pose serious health risks, and a healthcare professional must provide an alternative treatment first.
Contact your healthcare provider or the pharmacy where you filled the prescription to discuss a replacement or return instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

Full Refund

Healthcare guidance and product 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 ER 500 mg (30, 60, 90, 180 tablets)

Model:

NDC: 72789-009-30

NDC: 72789-009-60

NDC: 72789-009-90

NDC: 72789-009-93

Lot Numbers:

B20D23 (Exp. 07/31/21)

B20D67 (Exp. 07/31/21)

C20D55 (Exp. 12/31/21)

A20D92 (Exp. 07/31/21)

A20F59 (Exp. 07/31/21)

B20C16 (Exp. 07/31/21)

C20D63 (Exp. 12/31/21)

D20A45 (Exp. 12/31/21)

D20C80 (Exp. 12/31/21)

G20D46 (Exp. 04/30/22)

I20C57 (Exp. 04/30/22)

A20D90 (Exp. 07/31/21)

A20E77 (Exp. 07/31/21)

A20F69 (Exp. 07/31/21)

B20F43 (Exp. 07/31/21)

C20B14 (Exp. 12/31/21)

D20A41 (Exp. 12/31/21)

I20D94 (Exp. 04/30/22)

I20E56 (Exp. 04/30/22)

J20A28 (Exp. 04/30/22)

B20B96 (Exp. 07/31/21)

C20C28 (Exp. 12/31/21)

C20E58 (Exp. 12/31/21)

D20B17 (Exp. 12/31/21)

G20D91 (Exp. 04/30/22)

Date Ranges: Expiration 07/31/21, Expiration 12/31/21, Expiration 04/30/22

Product: metformin HCL ER 750 mg (30, 60 tablets)

Model:

NDC: 43063-902-30

NDC: 43063-902-60

Lot Numbers:

A20A97 (Exp. 04/30/21)

B20D25 (Exp. 04/30/21)

B20D69 (Exp. 07/31/21)

C20B95 (Exp. 07/31/21)

C20D60 (Exp. 07/31/21)

E20A50 (Exp. 07/31/21)

E20D37 (Exp. 03/31/22)

E20D73 (Exp. 03/31/22)

J19F04 (Exp. 01/31/21)

C20C15 (Exp. 07/31/21)

F20A14 (Exp. 03/31/22)

L19C15 (Exp. 04/30/21)

Date Ranges: Expiration 01/31/21, Expiration 04/30/21, Expiration 07/31/21, Expiration 03/31/22

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86600

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 2 products (1683 bottles; 125 bottles)

Distributed To: Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon, Wisconsin

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

Risk

What You Should Do

Check your prescription bottle label for the name 'metformin HCL ER' and the strengths 500 mg or 750 mg.

Verify if your bottle matches one of the following NDC numbers: 72789-009-30, 72789-009-60, 72789-009-90, 72789-009-93 (for 500 mg) or 43063-902-30, 43063-902-60 (for 750 mg).

Check for affected 500 mg lots including B20D23, B20D67 (Exp. 07/31/21), C20D55 (Exp. 12/31/21), A20D92, A20F59, B20C16 (Exp. 07/31/21), C20D63, D20A45, D20C80 (Exp. 12/31/21), G20D46, and I20C57 (Exp. 04/30/22).

Check for affected 750 mg lots including A20A97, B20D25 (Exp. 04/30/21), B20D69, C20B95, C20D60, E20A50 (Exp. 07/31/21), E20D37, E20D73 (Exp. 03/31/22), J19F04 (Exp. 01/31/21), C20C15 (Exp. 07/31/21), F20A14 (Exp. 03/31/22), and L19C15 (Exp. 04/30/21).

Do NOT stop taking your medication before talking to your doctor or pharmacist. Abruptly stopping metformin treatment for type 2 diabetes can pose serious health risks, and a healthcare professional must provide an alternative treatment first.

Contact your healthcare provider or the pharmacy where you filled the prescription to discuss a replacement or return instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Affected Products

Product: metformin HCL ER 500 mg (30, 60, 90, 180 tablets)

Model:

NDC: 72789-009-30

NDC: 72789-009-60

NDC: 72789-009-90

NDC: 72789-009-93

Lot Numbers:

B20D23 (Exp. 07/31/21)

B20D67 (Exp. 07/31/21)

C20D55 (Exp. 12/31/21)

A20D92 (Exp. 07/31/21)

A20F59 (Exp. 07/31/21)

B20C16 (Exp. 07/31/21)

C20D63 (Exp. 12/31/21)

D20A45 (Exp. 12/31/21)

D20C80 (Exp. 12/31/21)

G20D46 (Exp. 04/30/22)

I20C57 (Exp. 04/30/22)

A20D90 (Exp. 07/31/21)

A20E77 (Exp. 07/31/21)

A20F69 (Exp. 07/31/21)

B20F43 (Exp. 07/31/21)

C20B14 (Exp. 12/31/21)

D20A41 (Exp. 12/31/21)

I20D94 (Exp. 04/30/22)

I20E56 (Exp. 04/30/22)

J20A28 (Exp. 04/30/22)

B20B96 (Exp. 07/31/21)

C20C28 (Exp. 12/31/21)

C20E58 (Exp. 12/31/21)

D20B17 (Exp. 12/31/21)

G20D91 (Exp. 04/30/22)

Date Ranges: Expiration 07/31/21, Expiration 12/31/21, Expiration 04/30/22

Product: metformin HCL ER 750 mg (30, 60 tablets)

Model:

NDC: 43063-902-30

NDC: 43063-902-60

Lot Numbers:

A20A97 (Exp. 04/30/21)

B20D25 (Exp. 04/30/21)

B20D69 (Exp. 07/31/21)

C20B95 (Exp. 07/31/21)

C20D60 (Exp. 07/31/21)

E20A50 (Exp. 07/31/21)

E20D37 (Exp. 03/31/22)

E20D73 (Exp. 03/31/22)

J19F04 (Exp. 01/31/21)

C20C15 (Exp. 07/31/21)

F20A14 (Exp. 03/31/22)

L19C15 (Exp. 04/30/21)

Date Ranges: Expiration 01/31/21, Expiration 04/30/21, Expiration 07/31/21, Expiration 03/31/22

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86600

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 2 products (1683 bottles; 125 bottles)

Distributed To: Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon, Wisconsin