Medications & Supplements/Prescription Drugs

Direct Rx: Losartan Pot/HCTZ Recalled Due to N-Methylnitrosobutyric acid (NMBA) Impurity

Agency Publication Date: October 2, 2020

Summary

Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ (50/12.5 mg), a prescription medication used to treat high blood pressure. This recall was initiated because trace amounts of an impurity called N-Methylnitrosobutyric acid (NMBA) were detected during manufacturing. These affected bottles were distributed specifically in Florida. If you have this medication, you should contact your doctor or pharmacist to discuss your treatment options before stopping use.

Risk

The medication contains trace amounts of NMBA, which is a known impurity that may pose a long-term health risk if consumed over time. While no immediate illnesses have been reported, the presence of this substance violates safety standards for drug manufacturing.

What You Should Do

Check your prescription bottle label for Losartan Pot/HCTZ 50/12.5 mg with NDC number 61919-040-90.
Verify if your bottle matches Lot number 12DE1806 with an expiration date of 01/31/2021.
Contact your healthcare provider or pharmacist immediately to discuss your blood pressure treatment and to obtain a replacement medication.
Do not stop taking your medication without first talking to a healthcare professional, as the risk of stopping high blood pressure treatment suddenly may be greater than the risk of continued use until a replacement is available.
Return any unused product from the affected lot to your pharmacy for a refund and contact Direct Rx at their Dawsonville, Georgia location for further instructions.
For additional information or to report a problem, 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

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: Losartan Pot/HCTZ 50/12.5 mg (90 Tabs)

Model:

NDC 61919-040-90

Recall #: D-0032-2021

Lot Numbers:

12DE1806 (Exp. 01/31/2021)

Date Ranges: 01/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86487

Status: Resolved

Manufacturer: Direct Rx

Sold By: Direct Rx; Torrent Pharma, Inc.

Manufactured In: United States

Units Affected: 33 bottles

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 label for Losartan Pot/HCTZ 50/12.5 mg with NDC number 61919-040-90.

Verify if your bottle matches Lot number 12DE1806 with an expiration date of 01/31/2021.

Contact your healthcare provider or pharmacist immediately to discuss your blood pressure treatment and to obtain a replacement medication.

Do not stop taking your medication without first talking to a healthcare professional, as the risk of stopping high blood pressure treatment suddenly may be greater than the risk of continued use until a replacement is available.

Return any unused product from the affected lot to your pharmacy for a refund and contact Direct Rx at their Dawsonville, Georgia location for further instructions.

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