Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Lisinopril Tablets Recalled Due to Metal Contamination

Agency Publication Date: August 13, 2018

Summary

Lupin Pharmaceuticals Inc. is recalling 11,706 bottles of Lisinopril (10mg tablets), a medication used to treat high blood pressure and heart failure. The recall was initiated after a consumer reported finding a metal contaminant inside a single tablet. These affected 1,000-count bottles were distributed nationwide through mail-order pharmacies, supermarkets, and wholesale distributors.

Risk

The presence of a foreign metal substance in a tablet poses a risk of internal injury or choking if swallowed. While only one report has been received, the contamination indicates a potential manufacturing defect that could affect other tablets in the same batch.

What You Should Do

Check your prescription bottle for Lisinopril 10mg tablets in 1000-count bottles with NDC 68180-980-03.
Verify if your bottle matches Lot Number H800414 with an expiration date of 12/2019.
If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options before you stop taking the medication.
Return any unused product to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. at 111 S Calvert St Fl 21ST, Baltimore, Maryland, for further instructions.
Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program at 1-888-SAFEFDA (1-888-723-3332) or www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare 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: Lisinopril Tablets USP, 10mg (1000-count bottle)

Model:

NDC 68180-980-03

Lot Numbers:

H800414 (Exp. 12/2019)

Date Ranges: Expiration 12/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80789

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: distributors; mail order pharmacy; supermarkets

Manufactured In: United States

Units Affected: 11,706 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.

Summary

What You Should Do

Check your prescription bottle for Lisinopril 10mg tablets in 1000-count bottles with NDC 68180-980-03.

Verify if your bottle matches Lot Number H800414 with an expiration date of 12/2019.

If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options before you stop taking the medication.

Return any unused product to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. at 111 S Calvert St Fl 21ST, Baltimore, Maryland, for further instructions.

Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program at 1-888-SAFEFDA (1-888-723-3332) or www.fda.gov/safety/recalls.