Medications & Supplements/Prescription Drugs

PD-Rx Pharmaceuticals, Inc.: Metformin HCL ER 500mg Recalled for Excessive NDMA Impurity

Agency Publication Date: June 12, 2020

Summary

PD-Rx Pharmaceuticals, Inc. has recalled approximately 3,703 bottles of Metformin Hydrochloride Extended-Release (ER) USP, 500 mg tablets, a prescription medication used to manage blood sugar in patients with type 2 diabetes. The recall was initiated because FDA laboratory testing found levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit. Consumers who have these tablets should not stop taking their medication without first consulting a healthcare professional, as the risk of uncontrolled blood sugar may outweigh the risk of exposure to the impurity. You should contact your doctor or pharmacist to discuss alternative treatments or to receive a replacement prescription.

Risk

NDMA is classified as a probable human carcinogen, meaning it is a substance that could cause cancer with long-term exposure. While NDMA is a common environmental contaminant found in water and foods, the levels detected in these specific lots of Metformin exceed the safety thresholds established by the FDA.

What You Should Do

Check your medication bottle for the product name 'metFORMIN HCL ER USP 500 mg' and NDC numbers 43063-428-30, 43063-428-60, 43063-428-90, 43063-428-98, 43063-428-93, or 53746-0178-05.
Identify if your bottle belongs to one of the affected lots: D19C80, F19C39, H19A55, H19D56, I18E0, D19A66, E19C15, F19D60, E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, I19A56, E19C11, F19E33, I18E07, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, I18F43, HF06618A, or HF06718A, all with an expiration date of 06/30/2020.
If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss a replacement or alternative treatment; do NOT stop taking the medication until you have a replacement, as stopping diabetes medication can be dangerous.
Return any unused tablets from the recalled lots to your pharmacy for a refund and further instructions regarding disposal.
Contact PD-Rx Pharmaceuticals at their Oklahoma City facility or through your dispensing pharmacy if you have specific questions about this recall.
For additional questions or to report an adverse event, 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

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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 USP 500 mg (30 tablets)

Model:

NDC: 43063-428-30

Lot Numbers:

D19C80 (Exp. 06/30/2020)

F19C39 (Exp. 06/30/2020)

H19A55 (Exp. 06/30/2020)

H19D56 (Exp. 06/30/2020)

I18E0 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (60 tablets)

Model:

NDC: 43063-428-60

Lot Numbers:

D19A66 (Exp. 06/30/2020)

E19C15 (Exp. 06/30/2020)

F19D60 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (90 tablets)

Model:

NDC: 43063-428-90

Lot Numbers:

E19D32 (Exp. 06/30/2020)

J18B83 (Exp. 06/30/2020)

C19D25 (Exp. 06/30/2020)

C19E78 (Exp. 06/30/2020)

D19C60 (Exp. 06/30/2020)

D19D64 (Exp. 06/30/2020)

F19B27 (Exp. 06/30/2020)

G19A31 (Exp. 06/30/2020)

G19C41 (Exp. 06/30/2020)

I19A56 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (120 tablets)

Model:

NDC: 43063-428-98

Lot Numbers:

E19C11 (Exp. 06/30/2020)

F19E33 (Exp. 06/30/2020)

I18E07 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (180 tablets)

Model:

NDC: 43063-428-93

Lot Numbers:

D19D56 (Exp. 06/30/2020)

F19A51 (Exp. 06/30/2020)

H19A09 (Exp. 06/30/2020)

H19A81 (Exp. 06/30/2020)

H19B16 (Exp. 06/30/2020)

H19B77 (Exp. 06/30/2020)

H19C28 (Exp. 06/30/2020)

I18F43 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (500 tablets)

Model:

NDC: 53746-0178-05

Lot Numbers:

HF06618A (Exp. 06/30/2020)

HF06718A (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85827

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 3703 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

Risk

What You Should Do

Check your medication bottle for the product name 'metFORMIN HCL ER USP 500 mg' and NDC numbers 43063-428-30, 43063-428-60, 43063-428-90, 43063-428-98, 43063-428-93, or 53746-0178-05.

Identify if your bottle belongs to one of the affected lots: D19C80, F19C39, H19A55, H19D56, I18E0, D19A66, E19C15, F19D60, E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, I19A56, E19C11, F19E33, I18E07, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, I18F43, HF06618A, or HF06718A, all with an expiration date of 06/30/2020.

If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss a replacement or alternative treatment; do NOT stop taking the medication until you have a replacement, as stopping diabetes medication can be dangerous.

Return any unused tablets from the recalled lots to your pharmacy for a refund and further instructions regarding disposal.

Contact PD-Rx Pharmaceuticals at their Oklahoma City facility or through your dispensing pharmacy if you have specific questions about this recall.

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

Affected Products

Product: metFORMIN HCL ER USP 500 mg (30 tablets)

Model:

NDC: 43063-428-30

Lot Numbers:

D19C80 (Exp. 06/30/2020)

F19C39 (Exp. 06/30/2020)

H19A55 (Exp. 06/30/2020)

H19D56 (Exp. 06/30/2020)

I18E0 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (60 tablets)

Model:

NDC: 43063-428-60

Lot Numbers:

D19A66 (Exp. 06/30/2020)

E19C15 (Exp. 06/30/2020)

F19D60 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (90 tablets)

Model:

NDC: 43063-428-90

Lot Numbers:

E19D32 (Exp. 06/30/2020)

J18B83 (Exp. 06/30/2020)

C19D25 (Exp. 06/30/2020)

C19E78 (Exp. 06/30/2020)

D19C60 (Exp. 06/30/2020)

D19D64 (Exp. 06/30/2020)

F19B27 (Exp. 06/30/2020)

G19A31 (Exp. 06/30/2020)

G19C41 (Exp. 06/30/2020)

I19A56 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (120 tablets)

Model:

NDC: 43063-428-98

Lot Numbers:

E19C11 (Exp. 06/30/2020)

F19E33 (Exp. 06/30/2020)

I18E07 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (180 tablets)

Model:

NDC: 43063-428-93

Lot Numbers:

D19D56 (Exp. 06/30/2020)

F19A51 (Exp. 06/30/2020)

H19A09 (Exp. 06/30/2020)

H19A81 (Exp. 06/30/2020)

H19B16 (Exp. 06/30/2020)

H19B77 (Exp. 06/30/2020)

H19C28 (Exp. 06/30/2020)

I18F43 (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020

Product: metFORMIN HCL ER USP 500 mg (500 tablets)

Model:

NDC: 53746-0178-05

Lot Numbers:

HF06618A (Exp. 06/30/2020)

HF06718A (Exp. 06/30/2020)

Date Ranges: Expiration date 06/30/2020