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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 Specifications

Agency Publication Date: April 8, 2026
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Summary

Viatris, Inc. has recalled one lot of Xanax XR (alprazolam) extended-release 3 mg tablets due to a failure to meet dissolution specifications. These tablets are designed to release medication slowly over time, and a failure in dissolution means the medication may not be released at the intended rate, potentially impacting its effectiveness. No incidents or injuries have been reported to date in connection with this issue.

Risk

The product failed dissolution testing, which means the extended-release mechanism may not function correctly. This could lead to the medication being released too quickly or too slowly, potentially resulting in sub-therapeutic levels or an unexpected dose of alprazolam.

What You Should Do

  1. Check your medication bottle for Xanax XR (alprazolam) extended-release tablets, 3 mg, in 60-count bottles with NDC 58151-506-91.
  2. Verify if your bottle belongs to Lot 8177156 with an expiration date of 02/28/2027.
  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 the manufacturer 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 Tablets bottles)
Variants: 3 mg, Extended-release tablet
Lot Numbers:
8177156 (Exp Date: 02/28/2027)
NDC:
58151-506-91

Distributed by Viatris Specialty LLC, Morgantown, WV 06506

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98613
Status: Active
Manufacturer: Viatris, Inc.
Sold By: Viatris Specialty LLC
Manufactured In: Ireland, United States
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.