Medications & Supplements/Prescription Drugs

Losartan Potassium 50mg Tablets Recalled for Excessive Impurity Levels

Agency Publication Date: April 26, 2022

Summary

Preferred Pharmaceuticals, Inc. has recalled three lots of Losartan Potassium (losartan) 50mg tablets because they may contain an impurity called AZIDO at levels above the acceptable limit. The recall involves 44 bottles of 90 tablets and 33 bottles of 30 tablets. Losartan is a prescription medication used to treat high blood pressure and help protect the kidneys in patients with certain types of diabetes. No injuries or incidents have been reported to date.

Risk

The impurity AZIDO was found at levels exceeding safety standards. While no immediate health issues have been reported, long-term exposure to these impurities above acceptable limits may pose health risks. Patients should not stop taking their medication without consulting a healthcare provider, as the risk of untreated high blood pressure may be greater than the risk from the impurity.

What You Should Do

This recall affects Losartan Potassium Tablets USP 50mg distributed by Preferred Pharmaceuticals in both 30-count and 90-count bottles.
Check the medication bottle label for lot numbers E1321O, E2521H, or E2621F, all of which have an expiration date of 5/31/2023.
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 Preferred Pharmaceuticals, Inc. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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 Potassium Tab. USP 50mg

Variants: 50mg, 30 count bottle, 90 count bottle

Lot Numbers:

E1321O (Exp 5/31/2023)

E2521H (Exp 5/31/2023)

E2621F (Exp 5/31/2023)

Quantity affected: 44 Bottles of 90 Tablets and 33 Bottles of 30 Tablets. Manufactured by Lupin Pharmaceuticals, Inc. and Preferred Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90001

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: Preferred Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets

Distributed To: California, Indiana, 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

Risk

What You Should Do

This recall affects Losartan Potassium Tablets USP 50mg distributed by Preferred Pharmaceuticals in both 30-count and 90-count bottles.

Check the medication bottle label for lot numbers E1321O, E2521H, or E2621F, all of which have an expiration date of 5/31/2023.

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 Preferred Pharmaceuticals, Inc. directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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 Potassium Tab. USP 50mg

Variants: 50mg, 30 count bottle, 90 count bottle

Lot Numbers:

E1321O (Exp 5/31/2023)

E2521H (Exp 5/31/2023)

E2621F (Exp 5/31/2023)

Quantity affected: 44 Bottles of 90 Tablets and 33 Bottles of 30 Tablets. Manufactured by Lupin Pharmaceuticals, Inc. and Preferred Pharmaceuticals, Inc.