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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

American Health Packaging Tizanidine Tablets Recalled for Dissolution Issues

Agency Publication Date: June 30, 2023
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Summary

Amerisource Health Services LLC, doing business as American Health Packaging, is recalling 4,971 cartons of Tizanidine (4 mg) tablets, a prescription medication used to manage muscle spasms. The recall was issued because the tablets failed dissolution testing, meaning they may not dissolve properly in the body as intended. If the medication does not dissolve correctly, it may not provide the necessary treatment or could lead to inconsistent drug levels in the patient's system. No injuries or incidents have been reported in connection with this recall.

Risk

If the tablets fail to dissolve at the required rate, the patient may not receive the full therapeutic benefit of the medication, potentially leading to ineffective management of muscle spasms. In some cases, improper dissolution can cause unpredictable absorption of the drug into the bloodstream.

What You Should Do

  1. This recall affects American Health Packaging Tizanidine Tablets, USP, 4 mg, which were sold in cartons containing 100 tablets (arranged in 10 unit-dose blister packs of 10 tablets each).
  2. Identify affected products by checking for NDC 68084-645-01 on the carton and lot number 1004835 with an expiration date of 7/31/2023.
  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 Amerisource Health Services LLC 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 Tablets, USP, 4 mg (100 Tablets)by American Health Packaging
Variants: 4 mg, 100 Tablets, 10 unit-dose blister packs per carton
UPC Codes:
00368084645112
Lot Numbers:
1004835 (Exp 7/31/2023)
NDC:
68084-645-01

Packaged and Distributed by American Health Packaging; Recalled due to manufacturer Dr. Reddy's Laboratories, Inc. failure of dissolution specifications.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92607
Status: Resolved
Manufacturer: Amerisource Health Services LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4,971 cartons
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.