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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 Hydrochloride Tablets Recalled for Failed Stability Specifications

Agency Publication Date: July 5, 2023
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Summary

Preferred Pharmaceuticals, Inc. has recalled 541 bottles of Tizanidine Hydrochloride (4mg tablets), a muscle relaxant medication manufactured by Dr. Reddy's Laboratories. The recall was initiated because the tablets failed stability testing specifications, meaning the drug may not maintain its potency or quality throughout its shelf life. The affected products were distributed nationwide in 20, 30, 60, 90, and 120-count bottles.

Risk

The failure to meet stability specifications could result in the medication losing effectiveness before its expiration date. This may lead to inadequate treatment of muscle spasms or unpredictable therapeutic results.

What You Should Do

  1. This recall affects Tizanidine Hydrochloride 4mg tablets sold in 20, 30, 60, 90, and 120-count bottles with NDC numbers 68788-7781-2, 68788-7781-3, 68788-7781-6, 68788-7781-9, or 68788-7781-8.
  2. Check the lot number and expiration date printed on your medication bottle. Several specific lots are included in this recall. See the Affected Products section below for the full list of affected codes.
  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 Preferred Pharmaceuticals, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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 Hydrochloride (4mg)
Variants: 4mg, 20-count, 30-count, 60-count, 90-count, 120-count
Lot Numbers:
H1621S (Exp: 12/31/2023)
H2321C (Exp: 12/31/2023)
H0421B (Exp: 12/31/2023)
H1721E (Exp: 12/31/2023)
H1921T (Exp: 12/31/2023)
H3121M (Exp: 12/31/2023)
H2021G (Exp: 12/31/2023)
NDC:
68788-7781-2
68788-7781-3
68788-7781-6
68788-7781-9
68788-7781-8

Manufactured by Dr. Reddy's Laboratories Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92625
Status: Active
Manufacturer: Preferred Pharmaceuticals, Inc.
Manufactured In: United States
Units Affected: 541 Bottles
Distributed To: Nationwide
Agency Last Updated: July 7, 2023

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.