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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

Xanax XR (alprazolam) Recalled for Failed Dissolution Testing

Agency Publication Date: May 6, 2022
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Summary

Viatris Inc is voluntarily recalling 110 bottles of Xanax XR (alprazolam) 3 mg extended-release tablets. The recall was initiated because the product failed dissolution testing, which means the medication may not release properly into the body. This issue was identified through low out-of-specification test results for the tablets' ability to dissolve correctly.

Risk

If the tablets do not dissolve as designed, the medication may not be fully absorbed, potentially leading to less effective treatment for the patient's condition. No injuries or incidents related to this issue have been reported at this time.

What You Should Do

  1. The recalled product is Xanax XR (alprazolam) extended-release tablets, 3 mg, sold in 60-count bottles with NDC 0009-0068-07.
  2. Check your medication bottle for lot number DX7983 with an expiration date of 02/28/2023.
  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 Viatris Inc 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: Xanax XR (alprazolam) extended-release tablets (60-count bottle)
Variants: 3 mg strength, Extended-release
Lot Numbers:
DX7983 (Exp 02/28/2023)
NDC:
0009-0068-07

Recall #: D-0854-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90091
Status: Resolved
Manufacturer: Viatris Inc
Sold By: Pharmacia & Upjohn Co; Division of Pfizer Inc
Manufactured In: United States
Units Affected: 110 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 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.