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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/Hydrochlorothiazide Tablets Recalled for Potential Foreign Pill

Agency Publication Date: July 19, 2019
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Summary

Approximately 11,832 bottles of Lisinopril and Hydrochlorothiazide Tablets USP (20 mg/12.5 mg) are being recalled after a report that a bottle contained a single foreign tablet of Fenofibrate (145 mg). Taking an incorrect medication like Fenofibrate when you intend to take blood pressure medication can lead to dangerous health complications or inadequate treatment of your condition. These prescription tablets were manufactured by Lupin Pharmaceuticals and distributed in 500-count bottles nationwide. Consumers who have this medication should check their bottles immediately and consult with their healthcare provider.

Risk

A foreign tablet (Fenofibrate) was found inside a bottle of Lisinopril and Hydrochlorothiazide, meaning patients could accidentally ingest the wrong medication. This poses a risk of unintended side effects from Fenofibrate or a lack of necessary blood pressure control from the missing Lisinopril dose.

What You Should Do

  1. Check your prescription bottle for 'Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg' in a 500-count size.
  2. Verify if your bottle matches Lot Number H801815 with an Expiration Date of March 2021 and NDC 68180-519-02.
  3. If you identify an unusual or different-looking tablet in your bottle (specifically a Fenofibrate 145mg tablet), do not take it.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and how to obtain a safe replacement.
  5. Return any unused or affected product to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. at 111 S Calvert St Fl 21ST, Baltimore, MD for further instructions.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy return

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

Affected Products

Product: Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg (500-count bottle)
Model:
NDC 68180-519-02
Lot Numbers:
H801815 (Exp. March 2021)
Date Ranges: March 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83363
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 11,832 bottles
Distributed To: Nationwide
Agency Last Updated: July 31, 2019

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.