Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Lisinopril Tablets Recalled Due to Higher Dosage Tablets Found in Bottles

Agency Publication Date: June 8, 2020

Summary

Lupin Pharmaceuticals Inc. is recalling approximately 4,224 bottles of Lisinopril Tablets (5 mg), a medication used for blood pressure. The recall was initiated because bottles labeled as containing 5 mg tablets were found to contain 10 mg tablets instead. This product mix-up means patients may unknowingly take double their prescribed dose. Consumers should check their 1000-count bottles of Lisinopril 5 mg for the specific lot and NDC number listed below.

Risk

Taking 10 mg of Lisinopril when only 5 mg was prescribed can lead to dangerously low blood pressure (hypotension) or other complications related to an overdose of ACE inhibitors. The risk is heightened for patients who are sensitive to dosage changes or have underlying kidney conditions.

What You Should Do

Immediately check your medication bottle for Lisinopril Tablets, USP, 5 mg in 1000-count bottles with NDC 68180-513-03.
Verify if your bottle belongs to Lot # Q900683 with an expiration date of 10/31/2022.
If you identify that you have the affected product, contact your healthcare provider or pharmacist immediately for guidance on how to manage your blood pressure treatment.
Return any unused product to the place of purchase or pharmacy to receive a refund.
Contact Lupin Pharmaceuticals Inc. at their Baltimore, MD headquarters for further instructions regarding this product mix-up.
For additional information or to report a complaint, call 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

Product return and pharmacist 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, 5 mg (1000-count bottle)

Model:

NDC 68180-513-03

Recall #: D-1290-2020

Lot Numbers:

Q900683 (Exp. 10/31/2022)

Date Ranges: 10/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85770

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies; Healthcare providers

Manufactured In: India, United States

Units Affected: 4,224 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

Immediately check your medication bottle for Lisinopril Tablets, USP, 5 mg in 1000-count bottles with NDC 68180-513-03.

Verify if your bottle belongs to Lot # Q900683 with an expiration date of 10/31/2022.

If you identify that you have the affected product, contact your healthcare provider or pharmacist immediately for guidance on how to manage your blood pressure treatment.

Return any unused product to the place of purchase or pharmacy to receive a refund.

Contact Lupin Pharmaceuticals Inc. at their Baltimore, MD headquarters for further instructions regarding this product mix-up.

For additional information or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.