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Drug FDA Class II Ongoing Failed specifications

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

Viatris, Inc. Published Apr 15, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Viatris, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications

Hazards

Failed Dissolution · primary

Affected products (1)

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

XANAX

NDC: 58151-503, 58151-504, 58151-505, 58151-506, 58151-503-91, 58151-504-91, 58151-505-91, 58151-506-91
Lot codes: 8177156
Code info: Lot# 8177156, Exp Date: 02/28/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 17, 2026
  2. Published
    Apr 15, 2026
Recall number
D-0444-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.