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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

Torrent Pharma Inc.: Losartan Potassium Tablets Recalled Due to Impurity and Cancer Risk

Agency Publication Date: October 3, 2019
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Summary

Torrent Pharma Inc. has recalled 73,896 bottles of Losartan Potassium and Losartan Potassium/Hydrochlorothiazide tablets, which are used to treat high blood pressure. Testing confirmed that certain lots of these medications contain an impurity called N-Methylnitrosobutyric acid (NMBA) at levels higher than the daily limit allowed by the FDA. Consumers should contact their doctor or pharmacist to discuss an alternative treatment before stopping the medication, as stopping blood pressure medicine abruptly can pose immediate health risks. These prescription-only medications were distributed across the United States and Puerto Rico in bottles of 90 or 1,000 tablets.

Risk

The impurity NMBA is a known environmental contaminant and is classified as a potential human carcinogen. While no immediate injuries have been reported, long-term exposure to this substance above acceptable levels may increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle for the product name and NDC number. Affected products include Losartan Potassium (50mg and 100mg) and Losartan Potassium/Hydrochlorothiazide (50mg/12.5mg and 100mg/25mg).
  2. Verify the lot numbers on your packaging. Specifically look for Losartan Potassium 50mg Lot 4DU2E009; Losartan Potassium 100mg Lot 4DU3E009 (Exp 12/31/2020) or Lot 4DU3D018 (Exp 02/28/2021); Losartan Potassium/HCTZ 50mg/12.5mg Lot BEF7D051; or Losartan Potassium/HCTZ 100mg/25mg Lot 4P04D007.
  3. If your medication is part of the recall, contact your healthcare provider or pharmacist immediately to obtain a replacement or a different prescription. Do not stop taking your medication until you have a replacement, as the risk of harm to your health may be higher if the treatment is stopped suddenly without an alternative.
  4. Return any remaining unused product to the pharmacy where you purchased it for a refund and contact Torrent Pharma Inc. for further instructions regarding the return process.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Medication refund and healthcare consultation

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 (50mg, 1000 tablets per bottle)
Model:
NDC 13668-409-10
Lot Numbers:
4DU2E009
Product: Losartan Potassium Tablets, USP (100mg, 90 tablets per bottle)
Model:
NDC 13668-115-90
Lot Numbers:
4DU3E009 (Exp 12/31/2020)
Date Ranges: Expires 12/31/2020
Product: Losartan Potassium Tablets, USP (100mg, 1000 tablets per bottle)
Model:
NDC 13668-115-10
Lot Numbers:
4DU3D018 (Exp 02/28/2021)
Date Ranges: Expires 02/28/2021
Product: Losartan Potassium /Hydrochlorothiazide Tablets, USP (50mg/12.5mg, 90 tablets per bottle)
Model:
NDC 13668-116-90
Lot Numbers:
BEF7D051
Product: Losartan Potassium/ Hydrochlorothiazide Tablets, USP (100mg/25mg, 90 tablets per bottle)
Model:
NDC 13668-118-90
Lot Numbers:
4P04D007

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83840
Status: Active
Manufacturer: Torrent Pharma Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4 products (8,688 bottles; 39,432 bottles; 17,088 bottles; 8,688 bottles)
Distributed To: Nationwide

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.

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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.