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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

Lupin Pharmaceuticals Inc.: Lisinopril 20 mg Tablets Recalled for Product Mix-Up with 10 mg Tablets

Agency Publication Date: April 21, 2020
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Summary

Lupin Pharmaceuticals Inc. has recalled 11,808 bottles of Lisinopril Tablets USP (20 mg) because some bottles may contain 10 mg tablets instead of the intended 20 mg dose. Lisinopril is a prescription medication used to treat high blood pressure. The mix-up was discovered following a complaint where 10 mg tablets were found inside sealed bottles labeled as 20 mg/1000-count. If you are taking this medication, you may inadvertently receive only half of your prescribed dose, which could lead to poorly controlled blood pressure.

Risk

A product mix-up means patients may receive a lower dose of medication than prescribed. Taking 10 mg of Lisinopril when a 20 mg dose is required can result in ineffective treatment of hypertension, potentially leading to a dangerous increase in blood pressure or related cardiovascular complications.

What You Should Do

  1. Check your medication bottle to see if it is Lisinopril Tablets USP, 20 mg in a 1000-count white plastic bottle.
  2. Verify the identifying codes on the label: look for NDC 68180-0981-03, Lot number Q000255, and an expiration date of 01/2022.
  3. If your bottle matches these details, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a correct replacement.
  4. Return any unused product from the affected lot to your pharmacy to receive a refund.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore, MD location for further instructions regarding this recall.
  6. 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

Pharmaceutical product return and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Lisinopril Tablets USP, 20 mg (1000-count bottle)
Model:
NDC 68180-0981-03
Lot Numbers:
Q000255 (Exp 01/2022)
Date Ranges: Expiration 01/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85511
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 11,808 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.

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.