Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Losartan Potassium/HCTZ Tablets Recalled for Excessive Impurity Level

Agency Publication Date: May 2, 2019

Summary

RemedyRepack Inc. is recalling 44 bottles (totaling 3,960 tablets) of Losartan Potassium/HCTZ, 100 mg/12.5 mg tablets. This prescription blood pressure medication, originally manufactured by Torrent Pharmaceuticals, was found to contain an impurity called N-Methylnitrosobutyric acid (NMBA) at levels higher than the FDA's acceptable daily limit. While no injuries have been reported, consumers using this medication should contact their doctor or pharmacist immediately for advice before stopping use.

Risk

The medication contains an impurity (NMBA) that exceeds the interim acceptable daily intake level of 0.96 parts per million. Long-term exposure to this impurity above acceptable levels may increase the risk of cancer.

What You Should Do

Check your medication bottle for Losartan Potassium/HCTZ, 100 mg/12.5 mg tablets with NDC 70518-1560-00 and Lot Number B0517068-101618.
Verify if the expiration date on your 90-count HDPE bottle is 10/2019.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the current medication, as stopping blood pressure medicine abruptly can be dangerous.
Return any unused product to the pharmacy where it was purchased for a refund and contact RemedyRepack Inc. at their Indiana, PA location for further instructions.
For additional questions, 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 consultation and 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/HCTZ, 100 mg/12.5 mg Tablet (90-Count bottle)

Model:

NDC 70518-1560-00

Recall #: D-1270-2019

Lot Numbers:

B0517068-101618 (Exp. Date: 10/2019)

Date Ranges: 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82748

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: RemedyRepack Inc.

Manufactured In: United States

Units Affected: 44 HDPE bottles of 90 = 3,960 tablets

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 medication bottle for Losartan Potassium/HCTZ, 100 mg/12.5 mg tablets with NDC 70518-1560-00 and Lot Number B0517068-101618.

Verify if the expiration date on your 90-count HDPE bottle is 10/2019.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the current medication, as stopping blood pressure medicine abruptly can be dangerous.

Return any unused product to the pharmacy where it was purchased for a refund and contact RemedyRepack Inc. at their Indiana, PA location for further instructions.

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