FDA recall D-0444-2026

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

Reason for recall

Failed Dissolution Specifications

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-03-17

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0444-2026