HIGH

Xanax XR Alprazolam Recall Over Failed Dissolution Specifications Affects US Nationwide Distribution

Xanax XR extended-release alprazolam recall issued March 17, 2026 remains active. Viatris Specialty LLC distributes the drug nationwide in the United States. The issue is failed dissolution specifications. Patients and healthcare providers should stop using the product immediately and follow the recall instructions for guidance.

Quick Facts at a Glance

Recall Date
March 17, 2026
Hazard Level
HIGH
Brands
XANAX, Viatris Specialty LLC
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PREGNANT

Hazard Information

Failed Dissolution Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Viatris, Inc. or your healthcare provider for guidance. Notification method: Letter

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About This Product

Xanax XR is an extended-release form of alprazolam used to treat anxiety disorders. It is prescribed by clinicians and distributed nationwide.

Why This Is Dangerous

Failed dissolution specifications may lead to insufficient drug release or dose inaccuracies, potentially reducing effectiveness.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients may experience reduced anxiety control or withdrawal symptoms if treatment is interrupted.

Practical Guidance

How to identify if yours is affected

  1. Check the bottle for NDC 58151-506-91
  2. Inspect Lot# 8177156 and Exp 02/28/2027
  3. Verify 3 mg strength and 60-tablet count

Where to find product info

Look on the bottle label and packaging; FDA recall page for D-0444-2026

What timeline to expect

Recall processing and replacement/refund timelines vary by distributor

If the manufacturer is unresponsive

  • Contact your healthcare provider
  • File a consumer complaint with FDA if needed

How to prevent similar issues

  • Verify NDC before dispensing
  • Coordinate with pharmacists for substitution if needed
  • Follow FDA recall updates for replacement options

Documentation advice

Keep recall notices, pharmacy communications, and any replacement or refund documentation

Product Details

Brand: Xanax XR, Alprazolam, extended-release tablets. Dose: 3 mg, 60 tablets per bottle. Route: Rx only. Distributor: Viatris Specialty LLC, Morgantown, WV 06506, USA. Country of manufacture: Ireland. NDC: 58151-506-91. Lot numbers: Lot# 8177156. Expiration: 02/28/2027. Sold nationwide in the US.

Reported Incidents

No specific injuries or incidents are described in the provided information. The FDA notice does not list patient injuries or adverse events.

Key Facts

  • 3 mg Xanax XR tablets
  • 60 tablets per bottle
  • Lot# 8177156
  • Exp 02/28/2027
  • NDC 58151-506-91
  • Distributed nationwide in the US

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANT
Injury Types
OTHER

Product Details

Model Numbers
Lot# 8177156
Exp Date: 02/28/2027
UPC Codes
58151-503
58151-504
58151-505
+5 more
Affected States
ALL
Report Date
April 15, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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