Medications & Supplements/Prescription Drugs

PD-Rx Pharmaceuticals, Inc.: Metformin HCL ER 500 mg Recalled Due to NDMA Impurity Detection

Agency Publication Date: June 20, 2020

Summary

PD-Rx Pharmaceuticals, Inc. has recalled approximately 1,969 bottles of Metformin Hydrochloride Extended-Release (HCL ER) 500 mg tablets, a prescription medication used to treat type 2 diabetes. This recall was initiated because FDA analysis found levels of N-Nitrosodimethylamine (NDMA) that exceed acceptable safety limits. While NDMA is a common environmental contaminant found in water and foods, it is classified as a probable human carcinogen if consumed at high levels over a long period. No injuries or illnesses have been reported to date, but consumers are advised to consult their healthcare providers as stopping this medication suddenly can pose serious health risks.

Risk

The tablets contain NDMA levels above the daily acceptable intake limit. NDMA is a substance that could increase the risk of cancer in humans if exposed to levels above safe limits over an extended duration.

What You Should Do

Check your prescription bottle for 'metFORMIN HCL ER 500 mg' and verify the NDC and lot numbers to see if your medication is affected.
For 30-count bottles (NDC 72789-009-30), look for lot numbers A20B02, I19D03, J19A98, K19E32, or L19C86 with an expiration date of 12/31/2020.
For 60-count bottles (NDC 72789-009-60), look for lot numbers I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, or L19E74 with an expiration date of 12/31/2020.
For 90-count bottles (NDC 72789-009-90), look for lot numbers I19E91, I19F33, J19B88, J19E70, K19D26, or L19A65 with an expiration date of 12/31/2020.
For 180-count bottles (NDC 72789-009-93), look for lot numbers I19C21 (Exp 08/21/2020), I19C57, J19C21, J19C67, K19B53, L19C77, or L19E44 (Exp 12/31/2020). For 100-count bottles (NDC 49483-0623-01), look for lot XP9004 (Exp 12/31/2020).
Do NOT stop taking your medication without first speaking to your doctor or pharmacist, as the risks of uncontrolled blood sugar levels from stopping the drug may outweigh the risks of NDMA exposure.
Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription or returning your unused product to the place of purchase for a refund.
For more information or to report a concern, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug replacement and refund guidance

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 tablets)

Model:

NDC 72789-009-30

Lot Numbers:

A20B02 (Exp. 12/31/2020)

I19D03 (Exp. 12/31/2020)

J19A98 (Exp. 12/31/2020)

K19E32 (Exp. 12/31/2020)

L19C86 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (60 tablets)

Model:

NDC 72789-009-60

Lot Numbers:

I19D55 (Exp. 12/31/2020)

I19F50 (Exp. 12/31/2020)

K19A18 (Exp. 12/31/2020)

K19D87 (Exp. 12/31/2020)

L19B34 (Exp. 12/31/2020)

L19D23 (Exp. 12/31/2020)

L19E74 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (90 tablets)

Model:

NDC 72789-009-90

Lot Numbers:

I19E91 (Exp. 12/31/2020)

I19F33 (Exp. 12/31/2020)

J19B88 (Exp. 12/31/2020)

J19E70 (Exp. 12/31/2020)

K19D26 (Exp. 12/31/2020)

L19A65 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (180 tablets)

Model:

NDC 72789-009-93

Lot Numbers:

I19C21 (Exp. 08/21/2020)

I19C57 (Exp. 12/31/2020)

J19C21 (Exp. 12/31/2020)

J19C67 (Exp. 12/31/2020)

K19B53 (Exp. 12/31/2020)

L19C77 (Exp. 12/31/2020)

L19E44 (Exp. 12/31/2020)

Date Ranges: Exp. 08/21/2020, Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (100 tablets)

Model:

NDC 49483-0623-01

Lot Numbers:

XP9004 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85828

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: PD-Rx Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 1969 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 for 'metFORMIN HCL ER 500 mg' and verify the NDC and lot numbers to see if your medication is affected.

For 30-count bottles (NDC 72789-009-30), look for lot numbers A20B02, I19D03, J19A98, K19E32, or L19C86 with an expiration date of 12/31/2020.

For 60-count bottles (NDC 72789-009-60), look for lot numbers I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, or L19E74 with an expiration date of 12/31/2020.

For 90-count bottles (NDC 72789-009-90), look for lot numbers I19E91, I19F33, J19B88, J19E70, K19D26, or L19A65 with an expiration date of 12/31/2020.

For 180-count bottles (NDC 72789-009-93), look for lot numbers I19C21 (Exp 08/21/2020), I19C57, J19C21, J19C67, K19B53, L19C77, or L19E44 (Exp 12/31/2020). For 100-count bottles (NDC 49483-0623-01), look for lot XP9004 (Exp 12/31/2020).

Do NOT stop taking your medication without first speaking to your doctor or pharmacist, as the risks of uncontrolled blood sugar levels from stopping the drug may outweigh the risks of NDMA exposure.

Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription or returning your unused product to the place of purchase for a refund.

For more information or to report a concern, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: metFORMIN HCL ER 500 mg (30 tablets)

Model:

NDC 72789-009-30

Lot Numbers:

A20B02 (Exp. 12/31/2020)

I19D03 (Exp. 12/31/2020)

J19A98 (Exp. 12/31/2020)

K19E32 (Exp. 12/31/2020)

L19C86 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (60 tablets)

Model:

NDC 72789-009-60

Lot Numbers:

I19D55 (Exp. 12/31/2020)

I19F50 (Exp. 12/31/2020)

K19A18 (Exp. 12/31/2020)

K19D87 (Exp. 12/31/2020)

L19B34 (Exp. 12/31/2020)

L19D23 (Exp. 12/31/2020)

L19E74 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (90 tablets)

Model:

NDC 72789-009-90

Lot Numbers:

I19E91 (Exp. 12/31/2020)

I19F33 (Exp. 12/31/2020)

J19B88 (Exp. 12/31/2020)

J19E70 (Exp. 12/31/2020)

K19D26 (Exp. 12/31/2020)

L19A65 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (180 tablets)

Model:

NDC 72789-009-93

Lot Numbers:

I19C21 (Exp. 08/21/2020)

I19C57 (Exp. 12/31/2020)

J19C21 (Exp. 12/31/2020)

J19C67 (Exp. 12/31/2020)

K19B53 (Exp. 12/31/2020)

L19C77 (Exp. 12/31/2020)

L19E44 (Exp. 12/31/2020)

Date Ranges: Exp. 08/21/2020, Exp. 12/31/2020

Product: metFORMIN HCL ER 500 mg (100 tablets)

Model:

NDC 49483-0623-01

Lot Numbers:

XP9004 (Exp. 12/31/2020)

Date Ranges: Exp. 12/31/2020