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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

AVKARE Inc.: Losartan Potassium Tablets Recalled for Excessive Impurity (NMBA)

Agency Publication Date: May 1, 2019
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Summary

AVKARE Inc. has voluntarily recalled 2,284 cartons of Losartan Potassium Tablets USP (25 mg and 50 mg) after FDA laboratory testing found an impurity called N-Methylnitrosobutyric acid (NMBA) at levels higher than the acceptable daily limit. Losartan Potassium is a prescription medication used to treat high blood pressure and help protect the kidneys from damage due to diabetes. This recall affects unit dose packages distributed nationwide in the United States. Consumers should not stop taking their medication without consulting a healthcare professional first, as the risk of stopping high blood pressure treatment may outweigh the risk of the impurity.

Risk

The impurity NMBA is classified as a potential human carcinogen. While the risk of harm from a single dose is low, long-term exposure to levels above the interim acceptable limit of 0.96 parts per million may increase the risk of developing cancer over time.

What You Should Do

  1. Check your medication packaging for Losartan Potassium Tablets USP 50 mg with NDC 50268-517-15 and lot number 20121 (Exp. 6/30/2019).
  2. Check your medication packaging for Losartan Potassium Tablets USP 25 mg with NDC 50268-516-15 and lot number 19554 (Exp. 4/30/2019).
  3. Do NOT stop taking your medication immediately. Contact your healthcare provider or pharmacist to discuss your treatment options and obtain a replacement or alternative therapy before discontinuing the recalled drug.
  4. Return any unused portions of the recalled lots to the pharmacy where they were purchased for a refund.
  5. Contact AVKARE Inc. for further instructions regarding this recall.
  6. For additional questions or to report adverse effects, contact 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

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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 50 tablets (5x10) Unit Dose Rx Only
Model:
NDC 50268-517-15
Recall #: D-1249-2019
Lot Numbers:
20121 (Exp. 6/30/2019)
Date Ranges: Exp. 6/30/2019
Product: Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only
Model:
NDC 50268-516-15
Recall #: D-1250-2019
Lot Numbers:
19554 (Exp. 4/30/2019)
Date Ranges: Exp. 4/30/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82706
Status: Active
Manufacturer: AVKARE Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (1438 cartons (71,900 tablets); 846 cartons (42,300 tablets))
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.

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.