Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Tizanidine HCl Tablets Recalled Due to Foreign Glimepiride Tablet Presence

Agency Publication Date: September 17, 2018

Summary

Dr. Reddy's Laboratories is recalling 8,376 bottles of Tizanidine HCl (tizanidine) 2mg tablets because a foreign tablet, Glimepiride, was discovered inside a bottle of the medication. Tizanidine is a muscle relaxant, while Glimepiride is a medication used to treat type 2 diabetes by lowering blood sugar. Accidentally taking Glimepiride instead of your prescribed muscle relaxant could cause your blood sugar to drop to dangerously low levels, which can lead to serious health complications. You should check your 150-count prescription bottles for the affected lot number and contact your healthcare provider immediately.

Risk

The presence of a Glimepiride tablet in a bottle of Tizanidine HCl tablets poses a risk of accidental ingestion. Glimepiride is a potent blood-sugar-lowering medication; if taken by someone who does not need it, it can cause severe hypoglycemia (low blood sugar), which may lead to dizziness, confusion, seizures, or loss of consciousness.

What You Should Do

Check your prescription bottle label to see if you have Tizanidine HCl Tablets, USP 2mg in 150-count bottles with NDC 55111-179-15 and UPC 35511179153.
Specifically look for Lot Number T800304 with an Expiration Date of 03/2021 printed on the bottle.
If you identify an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on how to manage your medication and to report any adverse health effects.
Return any unused portions of the affected medication to your pharmacy for a refund and to ensure the product is properly handled.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office for further instructions regarding this recall.
For additional questions 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

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

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

Affected Products

Product: Tizanidine HCl Tablets, USP 2mg (150-count bottle)

Model:

NDC 55111-179-15

UPC Codes:

35511179153

Lot Numbers:

T800304 (Exp. 03/2021)

Date Ranges: Expiration 03/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80953

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 8376 units

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

Check your prescription bottle label to see if you have Tizanidine HCl Tablets, USP 2mg in 150-count bottles with NDC 55111-179-15 and UPC 35511179153.

Specifically look for Lot Number T800304 with an Expiration Date of 03/2021 printed on the bottle.

If you identify an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on how to manage your medication and to report any adverse health effects.

Return any unused portions of the affected medication to your pharmacy for a refund and to ensure the product is properly handled.

Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office for further instructions regarding this recall.

For additional questions 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.