FDA Drug recall D-0854-2022
Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc…
- FDA Drug
- Class II
- terminated
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc… by Viatris, citing failed Dissolution Specifications: low out of specification results for dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0854-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-28 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
Product
Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
Reason
Failed Dissolution Specifications: low out of specification results for dissolution.
Identifiers
| code_info | Lot #: DX7983, exp. date 02/28/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Viatris
- Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06…
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FDA Drug · Class II · 2025-01-22 · Viatris - Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505,…
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
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0854-2022%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.