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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

Preferred Pharmaceuticals, Inc: Losartan Potassium Tablets Recalled Due to Potential Carcinogenic Impurity

Agency Publication Date: May 16, 2019
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Summary

Preferred Pharmaceuticals, Inc. has recalled specific lots of Losartan Potassium (50mg), a prescription medication used to treat high blood pressure. Laboratory testing confirmed the presence of an impurity called N-Methylnitrosobutyric acid (NMBA) at levels higher than the daily intake limit allowed by the FDA. This recall affects 30-count and 90-count bottles that were manufactured by Torrent Pharma Inc. and distributed to pharmacies in California, Georgia, and Indiana.

Risk

The impurity NMBA is a known environmental contaminant and is classified as a potential human carcinogen, meaning long-term exposure above acceptable levels may increase the risk of cancer.

What You Should Do

  1. Check your prescription bottle for Losartan Potassium Tab. USP 50mg to see if it matches the affected NDC numbers and lot information.
  2. If you have a 30-count bottle (NDC 68788-0048-03), check for lot number A1818G (batch 01181807) with an expiration date of 3/2020.
  3. If you have a 90-count bottle (NDC 68788-0048-09), check for lot number L0517L (batch 12051712) with an expiration date of 3/2020.
  4. Do NOT stop taking your medication until you have spoken with your healthcare provider or pharmacist, as the risk of stopping your blood pressure medication suddenly may be higher than the risk of the impurity.
  5. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement or an alternative treatment.
  6. Return any unused product to your pharmacy for a refund and contact Preferred Pharmaceuticals, Inc. at their Anaheim, CA facility for further instructions.
  7. 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 Tab. USP 50mg (30-count bottle)
Model:
NDC 68788-0048-03
D-1281-2019
Lot Numbers:
A1818G (batch 01181807)
Date Ranges: Exp 3/2020
Product: Losartan Potassium Tab. USP 50mg (90-count bottle)
Model:
NDC 68788-0048-09
D-1281-2019
Lot Numbers:
L0517L (batch 12051712)
Date Ranges: Exp 3/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82791
Status: Resolved
Manufacturer: Preferred Pharmaceuticals, Inc
Sold By: pharmacies
Manufactured In: United States
Distributed To: California, Georgia, Indiana

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.