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Recall Observatory FDA recall evidence

Drug product

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

D-0444-2026

March 17, 2026

Class II

Product summary

Firm
Viatris, Inc.
Event
Event 98613
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0444-2026

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot# 8177156, Exp Date: 02/28/2027

Distribution pattern: US Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications