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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Tizanidine Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: July 19, 2023
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Summary

Dr Reddy's Laboratories Limited has recalled 17,548 1000-count bottles of Tizanidine Tablets USP (4 mg), a prescription medication used as a muscle relaxant. This recall was initiated after the tablets failed dissolution testing during a 24-month long-term stability study, which means the medication may not break down properly in the body as intended. Consumers who are currently taking this medication should consult with their healthcare provider or pharmacist regarding the recall.

Risk

When a medication fails dissolution specifications, it may not be absorbed correctly by the body, which can lead to the drug being less effective than required. No specific injuries or adverse health events have been reported in connection with this recall.

What You Should Do

  1. This recall affects 1000-count bottles of Tizanidine Tablets USP, 4 mg, with NDC 55111-180-10, manufactured by Dr. Reddy's Laboratories Limited.
  2. Check your medication container for lot numbers T2100585, T2100586, or T2100587 with an expiration date of December 2023.
  3. 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 Dr Reddy's Laboratories Limited for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (1000-count bottle)
Variants: 4 mg, Tablet, Rx Only
Lot Numbers:
T2100585 (Exp 12/2023)
T2100586 (Exp 12/2023)
T2100587 (Exp 12/2023)
NDC:
55111-180-10

Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92564
Status: Active
Manufacturer: Dr Reddy's Laboratories Limited
Sold By: Pharmacies
Manufactured In: India
Units Affected: 17,548 1000-countbottles
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 ยท 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.