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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Legacy Pharmaceutical Packaging LLC: Losartan Potassium Tablets Recalled for Potential Carcinogenic Impurity

Agency Publication Date: May 1, 2019
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Summary

Approximately 60,012 bottles of Losartan Potassium (50 mg) tablets, distributed by The Kroger Co., are being recalled because trace amounts of a potentially cancer-causing impurity called NMBA were found in the active ingredient. This medication is used to treat high blood pressure and help protect the kidneys in patients with type 2 diabetes. While there are no reports of adverse health effects from this specific batch, long-term exposure to this impurity is considered a health risk. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lot sold in Tennessee and Arizona.

Risk

The tablets contain trace amounts of N-Methylnitrosobutyric acid (NMBA), an impurity that is classified as a potential human carcinogen. Chronic exposure to this substance over a long period may increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle for 'Losartan Potassium Tablets, USP, 50 mg' in 30-tablet bottles with NDC 68645-494-54.
  2. Verify if your bottle belongs to Lot 181598 with an expiration date of 02/2021.
  3. Do NOT stop taking your medication before talking to your doctor or pharmacist, as the risk of stopping blood pressure treatment suddenly can be greater than the risk of the impurity.
  4. Contact your healthcare provider or pharmacist to discuss an alternative treatment or to see if a replacement is available.
  5. Return any unused product to your pharmacy for a refund and contact Legacy Pharmaceutical Packaging LLC for further instructions.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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 Tablets, USP, 50 mg (30 tablet bottle)
Model:
NDC 68645-494-54
Lot Numbers:
181598 (Exp 02/2021)
Date Ranges: February 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82710
Status: Active
Manufacturer: Legacy Pharmaceutical Packaging LLC
Sold By: The Kroger Co
Manufactured In: United States
Units Affected: 60,012 bottles
Distributed To: Tennessee, Arizona

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 ยท 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.