Medications & Supplements/Prescription Drugs

RemedyRepack Losartan HCTZ Recalled for Excessive Impurity Levels

Agency Publication Date: May 20, 2022

Summary

RemedyRepack Inc. has recalled 56 bottles of Losartan HCTZ (losartan potassium and hydrochlorothiazide) tablets, including 100/25 mg and 100/12.5 mg strengths in 90-count bottles. This recall was issued because the tablets were found to contain levels of an "AZIDO" impurity that exceed acceptable safety limits. While no injuries or adverse effects have been reported, the recall aims to prevent potential long-term health risks. These medications were distributed to pharmacies or healthcare facilities in Florida, South Carolina, and Virginia.

Risk

The AZIDO impurity is a potential carcinogen. Consuming this impurity in amounts higher than the daily acceptable intake over a long period may increase the risk of cancer.

What You Should Do

This recall affects Losartan HCTZ 100/25 mg and 100/12.5 mg tablets sold in 90-count bottles under the RemedyRepack label.
Check your medication bottle for the following lot numbers: B1329507-082921, B1348363-091421, B1387286-101021, B1390974-101221, B1426010-110521, B1364261-092721, B1377667-100521, B1412576-102621, or B1436925-111321. See the Affected Products section below for the full list of affected codes.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 (losartan potassium and hydrochlorothiazide) 100/25 mg (90-count bottle)

Variants: 100/25 mg, Tablet

Lot Numbers:

B1329507-082921 (Exp 08/31/2022)

B1348363-091421 (Exp 09/30/2022)

B1387286-101021 (Exp 10/31/2022)

B1390974-101221 (Exp 10/31/2022)

B1426010-110521 (Exp 11/30/2022)

NDC:

70518-2578-00

68180-0217-09

Quantity: 26 bottles (2,340 tablets)

Product: Losartan HCTZ (losartan potassium and hydrochlorothiazide) 100/12.5 mg (90-count bottle)

Variants: 100/12.5 mg, Tablet

Lot Numbers:

B1364261-092721 (Exp 09/30/2022)

B1377667-100521 (Exp 10/31/2022)

B1412576-102621 (Exp 10/31/2022)

B1436925-111321 (Exp 11/30/2022)

NDC:

70518-2564-00

68180-0216-09

Quantity: 30 bottles (2,700 tablets)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90127

Status: Resolved

Manufacturer: RemedyRepack Inc.

Manufactured In: United States

Units Affected: 2 products (26/90 count bottles = 2,340 tablets; 30 bottles/90 count = 2,700 tablets)

Distributed To: Florida, South Carolina, Virginia

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 100/25 mg and 100/12.5 mg tablets sold in 90-count bottles under the RemedyRepack label.

Check your medication bottle for the following lot numbers: B1329507-082921, B1348363-091421, B1387286-101021, B1390974-101221, B1426010-110521, B1364261-092721, B1377667-100521, B1412576-102621, or B1436925-111321. See the Affected Products section below for the full list of affected codes.

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 the manufacturer for further instructions.

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

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 (losartan potassium and hydrochlorothiazide) 100/25 mg (90-count bottle)

Variants: 100/25 mg, Tablet

Lot Numbers:

B1329507-082921 (Exp 08/31/2022)

B1348363-091421 (Exp 09/30/2022)

B1387286-101021 (Exp 10/31/2022)

B1390974-101221 (Exp 10/31/2022)

B1426010-110521 (Exp 11/30/2022)

NDC:

70518-2578-00

68180-0217-09

Quantity: 26 bottles (2,340 tablets)

Product: Losartan HCTZ (losartan potassium and hydrochlorothiazide) 100/12.5 mg (90-count bottle)

Variants: 100/12.5 mg, Tablet

Lot Numbers:

B1364261-092721 (Exp 09/30/2022)

B1377667-100521 (Exp 10/31/2022)

B1412576-102621 (Exp 10/31/2022)

B1436925-111321 (Exp 11/30/2022)

NDC:

70518-2564-00

68180-0216-09

Quantity: 30 bottles (2,700 tablets)