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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

RemedyRepack Inc.: Losartan 50mg Tablets Recalled for Potential Impurity Contamination

Agency Publication Date: April 5, 2019
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Summary

RemedyRepack Inc. is recalling 33 blister cards (a total of 990 tablets) of Losartan (50mg), a medication used to treat high blood pressure. The recall was initiated because the active ingredient in the medication was found to contain trace amounts of N-Methylnitrosobutyric acid (NMBA), an unexpected impurity. This impurity was detected during testing, though no specific patient injuries or adverse events have been reported to date for this specific lot.

Risk

NMBA is a suspected human carcinogen. Exposure to this impurity over a long period of time may increase the risk of developing cancer, although the immediate risk from short-term use is generally low.

What You Should Do

  1. Check your medication packaging for Losartan 50mg Tablets in 30-count blister cards with Lot Number J0328416-101518 and an Expiration Date of 10/2019.
  2. Verify the NDC number 70518-0588-01 is printed on your medication label or blister card.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment; do not stop taking your blood pressure medication until you have a replacement, as the risk of stopping suddenly may be greater than the risk of exposure to the impurity.
  4. Return any unused portions of the affected lot J0328416-101518 to your pharmacy for a refund and further instructions.
  5. Contact RemedyRepack Inc. at their distribution facility in Indiana, Pennsylvania, for more information regarding this recall.
  6. For additional questions or to report a problem, 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

Healthcare provider consultation and pharmacy 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 50mg Tablet (30 count blister card)
Model:
70518-0588-01
D-1081-2019
Lot Numbers:
J0328416-101518 (Exp. Date: 10/2019)
Date Ranges: 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82532
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: Miami, FL customer
Manufactured In: United States
Units Affected: 33 blister cards of 30 = 990 tablets
Distributed To: 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 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.