Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Tizanidine HCl Tablets Recalled Due to Shaved Tablets

Agency Publication Date: August 18, 2021

Summary

Dr. Reddy's Laboratories is recalling approximately 37,560 bottles of Tizanidine HCl (tizanidine), a prescription muscle relaxant. The recall was initiated because some tablets in the affected bottles were found to be "shaved," meaning they may not meet the required physical specifications. Consumers should check their medication bottles immediately and contact their healthcare provider or pharmacist regarding the continued use of this product.

Risk

A shaved tablet may contain less than the intended dose of medication, which could lead to reduced effectiveness in managing muscle spasms. While no injuries have been reported, inconsistent dosing can complicate treatment plans.

What You Should Do

Check your prescription bottle for Tizanidine HCl Tablets, USP 4 mg in 150-count bottles with NDC 55111-180-15.
Verify if your bottle belongs to Lot T2000471 with an expiration date of 09/2023.
If you have an affected bottle, contact your healthcare provider or pharmacist for guidance on whether to continue your current dose or obtain a replacement.
Return any unused or damaged medication to the pharmacy where it was purchased for a refund and further instructions.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office for additional product information or recall details.
For general questions regarding drug safety, contact 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

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 4 mg (150-count bottle)

Model:

NDC 55111-180-15

Recall #: D-0750-2021

Lot Numbers:

T2000471 (Exp 09/2023)

Date Ranges: 09/2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88309

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 37560 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 Tizanidine HCl Tablets, USP 4 mg in 150-count bottles with NDC 55111-180-15.

Verify if your bottle belongs to Lot T2000471 with an expiration date of 09/2023.

If you have an affected bottle, contact your healthcare provider or pharmacist for guidance on whether to continue your current dose or obtain a replacement.

Return any unused or damaged medication to the pharmacy where it was purchased for a refund and further instructions.

Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office for additional product information or recall details.

For general questions regarding drug safety, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.