Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Lisinopril 10mg Tablets Recalled Due to Presence of 20mg Tablets

Agency Publication Date: July 28, 2020

Summary

Lupin Pharmaceuticals Inc. has recalled 11,688 bottles of Lisinopril (lisinopril) 10 mg tablets, a medication used to treat high blood pressure. The recall was initiated because 20 mg tablets were found inside a bottle labeled as 10 mg. This packaging error means patients may unknowingly take double their prescribed dose. Consumers should immediately check their medication bottles and contact their healthcare provider or pharmacist for guidance.

Risk

Taking a higher dose of Lisinopril than prescribed can lead to dangerously low blood pressure (hypotension) or kidney dysfunction. No specific injuries or adverse events have been reported to date, but the presence of a higher-strength tablet poses a significant health risk to patients following a strict 10 mg regimen.

What You Should Do

Check your Lisinopril 10 mg medication bottle for Lot number Q000232 and an expiration date of 01/2022. The affected product is a 1000-count bottle with NDC 68001-334-08.
Inspect the tablets inside the bottle; the recall is specifically for 20 mg tablets found in 10 mg labeled containers.
If you identify an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a correct replacement.
Return any unused or incorrectly labeled product to the pharmacy where it was purchased for a refund.
Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters if you have further questions regarding this recall.
For additional information or to report adverse reactions, 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

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, 10 mg (1000 count bottles)

Model:

NDC 68001-334-08

Recall #: D-1413-2020

Lot Numbers:

Q000232 (exp. date 01/2022)

Date Ranges: 01/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86053

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: BluePoint Laboratories

Manufactured In: India, United States

Units Affected: 11,688 bottles

Distributed To: Ohio

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

Check your Lisinopril 10 mg medication bottle for Lot number Q000232 and an expiration date of 01/2022. The affected product is a 1000-count bottle with NDC 68001-334-08.

Inspect the tablets inside the bottle; the recall is specifically for 20 mg tablets found in 10 mg labeled containers.

If you identify an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a correct replacement.

Return any unused or incorrectly labeled product to the pharmacy where it was purchased for a refund.

Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters if you have further questions regarding this recall.

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