Medications & Supplements/Prescription Drugs

Losartan HCTZ Recalled for Excessive Impurity Levels

Agency Publication Date: May 20, 2022

Summary

RemedyRepack Inc. has voluntarily recalled 22 bottles of Losartan HCTZ (50/12.5 mg) because tests found levels of an impurity known as AZIDO that were above acceptable safety limits. The recall affects 90-count bottles of this prescription heart and blood pressure medication that were distributed to Florida. No injuries or incidents have been reported in connection with this issue.

Risk

The presence of AZIDO impurity levels above acceptable limits may pose a health risk to patients over long-term use. While no immediate health issues have been reported, the medication does not meet manufacturing safety standards.

What You Should Do

This recall affects Losartan HCTZ 50/12.5 mg tablets sold in 90-count bottles with repackaged NDC 70518-3231-00. Check the label on your bottle for lot numbers B1377711-100521 or B1412137-102621, both of which have an expiration date of 10/31/2022.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact RemedyRepack Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Losartan HCTZ 50/12.5 mg, 90 count bottle

Variants: 50/12.5 mg, 90 count

Lot Numbers:

B1377711-100521 (Exp 10/31/2022)

B1412137-102621 (Exp 10/31/2022)

NDC:

70518-3231-00

33342-0050-10

Quantity: 22 bottles affected. Original NDC# 33342-0050-10.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90134

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: Pharmacies in Florida

Manufactured In: United States

Units Affected: 22 bottles/90 count each

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

This recall affects Losartan HCTZ 50/12.5 mg tablets sold in 90-count bottles with repackaged NDC 70518-3231-00. Check the label on your bottle for lot numbers B1377711-100521 or B1412137-102621, both of which have an expiration date of 10/31/2022.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact RemedyRepack Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.