Xanax XR — Class II drug recall D-0854-2022
Terminated recall by Viatris Inc, reported 2022-05-18, distributed nationwide. Failed Dissolution Specifications: low out of specification results for dissolution.
| Recall number | D-0854-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viatris Inc, Canonsburg, PA, United States |
| Recall initiated | 2022-04-28 |
| Classified | 2022-05-06 |
| Reported by FDA | 2022-05-18 |
| Terminated | 2023-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 110 bottles |
| Reason classes | specification failure |
| NDC | 00009-0068-07 |
| Lot numbers | DX7983 |
| Expiration dates | 2023-02-28 |
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 for recall
Failed Dissolution Specifications: low out of specification results for dissolution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0854-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.