FDA Recall D-0444-2026
Viatris, Inc. · Canonsburg, PA
Class II Ongoing 58 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0444-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2026-03-17
- Classified by FDA Center
- 2026-04-08
- FDA published
- 2026-04-15
- Recalling firm
- Viatris, Inc.
- Firm location
- Canonsburg, PA
Drug identification
- Brand name(s)
- XANAX
- Generic name(s)
- ALPRAZOLAM
- Manufacturer(s)
- Viatris Specialty LLC
- NDC(s)
58151-503, 58151-504, 58151-505, 58151-506- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.