Medications & Supplements/Prescription Drugs

Lupin Lisinopril and Hydrochlorothiazide Tablets Recalled for Product Mix-Up

Agency Publication Date: July 17, 2025

Summary

Lupin Pharmaceuticals Inc. is recalling approximately 58,968 bottles of Lisinopril and Hydrochlorothiazide (20mg/12.5mg) tablets. The recall was initiated after a report that a sealed bottle contained a foreign tablet identified as Atazanavir and Ritonavir (300mg/100mg). The affected products were distributed nationwide in 100-count bottles.

Risk

Taking an unintended medication like Atazanavir and Ritonavir (an HIV treatment) instead of the prescribed blood pressure medicine could lead to serious drug interactions or adverse reactions. Patients would also miss their intended dose of Lisinopril and Hydrochlorothiazide, potentially leading to uncontrolled high blood pressure.

What You Should Do

This recall affects Lisinopril and Hydrochlorothiazide Tablets USP (20mg/12.5mg) sold in 100-count bottles under NDC 68180-519-01.
Identify affected bottles by checking for lot number QA01081 with an expiration date of April 2027. Consumers should also inspect the contents of the bottle for any tablets that look different from the prescribed medication.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lisinopril and Hydrochlorothiazide Tablets USP (100-count bottle)by Lupin Pharmaceuticals, Inc.

Variants: 20mg/12.5mg

Lot Numbers:

QA01081 (Exp. April 2027)

NDC:

68180-519-01

Recall #: D-0532-2025; Rx only; Manufactured by Lupin Limited in India

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97118

Status: Active

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Retail Pharmacies

Manufactured In: India

Units Affected: 58,968 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

Risk

What You Should Do

This recall affects Lisinopril and Hydrochlorothiazide Tablets USP (20mg/12.5mg) sold in 100-count bottles under NDC 68180-519-01.

Identify affected bottles by checking for lot number QA01081 with an expiration date of April 2027. Consumers should also inspect the contents of the bottle for any tablets that look different from the prescribed medication.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.