FDA Drug recall D-0444-2026
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06… by Viatris, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0444-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-17 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 58151-503-91 |
|---|---|
| ndc | 58151-504-91 |
| ndc | 58151-505-91 |
| ndc | 58151-506-91 |
| code_info | Lot# 8177156, Exp Date: 02/28/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-01-22 · Viatris - Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10),…
FDA Drug · Class II · 2024-12-18 · Viatris - Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10),…
FDA Drug · Class II · 2024-12-18 · Viatris - Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10),…
FDA Drug · Class II · 2024-12-18 · Viatris
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0444-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.