Medications & Supplements/Prescription Drugs

Dr. Reddy's Tizanidine 4mg Tablets Recalled for Containing 2mg Tablets

Agency Publication Date: January 11, 2024

Summary

Dr. Reddy's Laboratories, Inc. has voluntarily recalled 38,952 bottles of Tizanidine (4mg), a prescription muscle relaxant, because some bottles may contain 2mg tablets instead of the intended 4mg tablets. The recall affects 150-count bottles manufactured in India and the United States. No incidents or injuries have been reported to date in connection with this mislabeling issue.

Risk

Taking a 2mg tablet when a 4mg dose was prescribed results in receiving only half of the intended medication. This can lead to the return or worsening of muscle spasms and inadequate management of the patient's condition.

What You Should Do

This recall involves 150-count bottles of Tizanidine Tablets, USP 4mg (NDC 55111-180-15) which can be identified by lot number T2304007 and an expiration date of 7/31/2026.
If you are taking this medication, examine your tablets to ensure they match the 4mg strength described on your prescription label; the recall was initiated because 2mg tablets were found inside bottles labeled as 4mg.
If you have health concerns or notice that your symptoms are not being managed as expected, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

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: Tizanidine Tablets, USP 4mg (150-count bottle)

Variants: 4mg, 150-count bottle, Tablet, Rx only

Lot Numbers:

T2304007 (Exp 7/31/2026)

NDC:

55111-180-15

Recall #: D-0223-2024; Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93713

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 38,952 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

This recall involves 150-count bottles of Tizanidine Tablets, USP 4mg (NDC 55111-180-15) which can be identified by lot number T2304007 and an expiration date of 7/31/2026.

If you are taking this medication, examine your tablets to ensure they match the 4mg strength described on your prescription label; the recall was initiated because 2mg tablets were found inside bottles labeled as 4mg.

If you have health concerns or notice that your symptoms are not being managed as expected, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.

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