Medications & Supplements/Prescription Drugs

PD-Rx Pharmaceuticals, Inc.: Losartan Potassium Tablets Recalled for Impurity (NMBA)

Agency Publication Date: April 26, 2021

Summary

Approximately 576 bottles of Losartan Potassium (50 mg), a prescription medication used to treat high blood pressure, have been recalled because they may contain trace amounts of a chemical impurity called NMBA. This recall affects 60-tablet and 90-tablet bottles packaged by PD-Rx Pharmaceuticals that were distributed in 14 states. If you take this medication, do not stop taking it without first consulting your healthcare provider or pharmacist, as the risk of stopping the medicine suddenly may be greater than the risk of the impurity.

Risk

The product was found to contain trace amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), which is a known environmental contaminant and potential human carcinogen. Exposure to this impurity above acceptable levels over a long period may increase the risk of cancer.

What You Should Do

Check your prescription bottle for 'Losartan Potassium USP, 50 mg' packaged by PD-Rx Pharmaceuticals with NDC numbers 43063-854-60 (60 tablets) or 43063-0854-90 (90 tablets).
Verify if your bottle matches one of the following lot numbers and expiration dates: A19B99 (Exp. 11/30/2019), B19A26 (Exp. 11/30/2019), B19A69 (Exp. 11/30/2019), E18F12 (Exp. 09/30/19), F18A12 (Exp. 09/30/19), F18F06 (Exp. 09/30/19), G18B43 (Exp. 09/30/19), G18C43 (Exp. 09/30/19), G18F75 (Exp. 09/30/19), H18D55 (Exp. 09/30/19), I18A11 (Exp. 09/30/19), I18E32 (Exp. 09/30/19), J18A90 (Exp. 09/30/19), J18D50 (Exp. 11/30/2019), or L18D01 (Exp. 11/30/2019).
If your medication is part of the recall, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the current tablets.
Contact the pharmacy where you purchased the medication to arrange for a refund and instructions on how to return any remaining tablets.
For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Losartan Potassium USP (50 mg, 60 Tablets)

Model:

NDC: 43063-854-60

Lot Numbers:

A19B99 (Exp. 11/30/2019)

B19A26 (Exp. 11/30/2019)

B19A69 (Exp. 11/30/2019)

E18F12 (Exp. 09/30/19)

F18A12 (Exp. 09/30/19)

F18F06 (Exp. 09/30/19)

G18B43 (Exp. 09/30/19)

G18C43 (Exp. 09/30/19)

G18F75 (Exp. 09/30/19)

H18D55 (Exp. 09/30/19)

I18A11 (Exp. 09/30/19)

I18E32 (Exp. 09/30/19)

J18A90 (Exp. 09/30/19)

J18D50 (Exp. 11/30/2019)

L18D01 (Exp. 11/30/2019)

Product: Losartan Potassium USP (50 mg, 90 Tablets)

Model:

NDC: 43063-0854-90

Lot Numbers:

A19B99 (Exp. 11/30/2019)

B19A26 (Exp. 11/30/2019)

B19A69 (Exp. 11/30/2019)

E18F12 (Exp. 09/30/19)

F18A12 (Exp. 09/30/19)

F18F06 (Exp. 09/30/19)

G18B43 (Exp. 09/30/19)

G18C43 (Exp. 09/30/19)

G18F75 (Exp. 09/30/19)

H18D55 (Exp. 09/30/19)

I18A11 (Exp. 09/30/19)

I18E32 (Exp. 09/30/19)

J18A90 (Exp. 09/30/19)

J18D50 (Exp. 11/30/2019)

L18D01 (Exp. 11/30/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87774

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 576 bottles

Distributed To: Alaska, Arizona, California, Colorado, Florida, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Ohio, Oregon, Wisconsin, Wyoming

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 'Losartan Potassium USP, 50 mg' packaged by PD-Rx Pharmaceuticals with NDC numbers 43063-854-60 (60 tablets) or 43063-0854-90 (90 tablets).

Verify if your bottle matches one of the following lot numbers and expiration dates: A19B99 (Exp. 11/30/2019), B19A26 (Exp. 11/30/2019), B19A69 (Exp. 11/30/2019), E18F12 (Exp. 09/30/19), F18A12 (Exp. 09/30/19), F18F06 (Exp. 09/30/19), G18B43 (Exp. 09/30/19), G18C43 (Exp. 09/30/19), G18F75 (Exp. 09/30/19), H18D55 (Exp. 09/30/19), I18A11 (Exp. 09/30/19), I18E32 (Exp. 09/30/19), J18A90 (Exp. 09/30/19), J18D50 (Exp. 11/30/2019), or L18D01 (Exp. 11/30/2019).

If your medication is part of the recall, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the current tablets.

Contact the pharmacy where you purchased the medication to arrange for a refund and instructions on how to return any remaining tablets.

For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: Losartan Potassium USP (50 mg, 60 Tablets)

Model:

NDC: 43063-854-60

Lot Numbers:

A19B99 (Exp. 11/30/2019)

B19A26 (Exp. 11/30/2019)

B19A69 (Exp. 11/30/2019)

E18F12 (Exp. 09/30/19)

F18A12 (Exp. 09/30/19)

F18F06 (Exp. 09/30/19)

G18B43 (Exp. 09/30/19)

G18C43 (Exp. 09/30/19)

G18F75 (Exp. 09/30/19)

H18D55 (Exp. 09/30/19)

I18A11 (Exp. 09/30/19)

I18E32 (Exp. 09/30/19)

J18A90 (Exp. 09/30/19)

J18D50 (Exp. 11/30/2019)

L18D01 (Exp. 11/30/2019)

Product: Losartan Potassium USP (50 mg, 90 Tablets)

Model:

NDC: 43063-0854-90

Lot Numbers:

A19B99 (Exp. 11/30/2019)

B19A26 (Exp. 11/30/2019)

B19A69 (Exp. 11/30/2019)

E18F12 (Exp. 09/30/19)

F18A12 (Exp. 09/30/19)

F18F06 (Exp. 09/30/19)

G18B43 (Exp. 09/30/19)

G18C43 (Exp. 09/30/19)

G18F75 (Exp. 09/30/19)

H18D55 (Exp. 09/30/19)

I18A11 (Exp. 09/30/19)

I18E32 (Exp. 09/30/19)

J18A90 (Exp. 09/30/19)

J18D50 (Exp. 11/30/2019)

L18D01 (Exp. 11/30/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87774

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 576 bottles

Distributed To: Alaska, Arizona, California, Colorado, Florida, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Ohio, Oregon, Wisconsin, Wyoming