Xanax Tablet, Extended Release
FDA Recall NDC 58151-503
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Xanax (NDC 58151-503). A significant event, classified as Class II, was initiated on Mar 17, 2026 by Viatris Specialty Llc. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Mar 17, 2026
Apr 15, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98613
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
Batch or Lot Expiration Information
Lot# 8177156, Exp Date: 02/28/2027
Affected Packages Involved in this Recall
58151-503-91Product
58151-504-91Product
58151-505-91Product
58151-506-91Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
