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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

Alprazolam XR (Xanax XR) Recalled for Low Dissolution Results

Agency Publication Date: May 3, 2022
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Summary

Viatris Inc. is recalling 6,789 bottles of alprazolam XR (Xanax XR) 3 mg extended-release tablets because the medication failed dissolution testing. This means the tablets may not release the active ingredient into the body as intended, which could make the treatment less effective. The 60-count bottles were distributed nationwide by Greenstone LLC and were sold with lot number EH8348 and an expiration date of August 2023.

Risk

Low dissolution results mean the medication may not break down and release correctly in the body, potentially resulting in a patient not receiving the full intended dose of the drug. No injuries or adverse events have been reported to date.

What You Should Do

  1. This recall affects 60-count bottles of alprazolam XR extended-release tablets (3 mg) with NDC 59762-0068-1, lot number EH8348, and an expiration date of August 2023.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. 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) or visit www.fda.gov/safety/recalls for additional information.

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: alprazolam XR extended-release tablets (3 mg)
Variants: 3 mg, Extended-release tablet, 60-count bottle
Lot Numbers:
EH8348 (Exp August 2023)
NDC:
59762-0068-1

Distributed by Greenstone LLC; Recall #: D-0844-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90045
Status: Resolved
Manufacturer: Viatris Inc
Sold By: Greenstone LLC
Manufactured In: United States
Units Affected: 6,789 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.