FDA DrugsClass II
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl...
Published: April 15, 2026Recall ID: D-0444-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Canonsburg |
| State | PA |
| Openfda › Nui › 1 | N0000175694 |
| Openfda › Nui › 2 | M0002356 |
| Openfda › Upc › 1 | 0358151506910 |
| Openfda › Upc › 2 | 0358151504916 |
| Openfda › Upc › 3 | 0358151503919 |
| Openfda › Upc › 4 | 0358151505913 |
| Openfda › Unii | YU55MQ3IZY |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 433798 |
| Openfda › Rxcui › 2 | 433799 |
| Openfda › Rxcui › 3 | 433800 |
| Openfda › Rxcui › 4 | 433801 |
| Openfda › Rxcui › 5 | 687022 |
| Openfda › Rxcui › 6 | 687023 |
| Openfda › Rxcui › 7 | 687024 |
| Openfda › Rxcui › 8 | 687025 |
| Openfda › Spl id | 7ceb0a8d-f766-4806-a289-652080edf4a3 |
| Openfda › Brand name | XANAX |
| Openfda › Spl set id | c8990714-c2f5-4b0c-9f1c-91d77156d962 |
| Openfda › Package ndc › 1 | 58151-503-91 |
| Openfda › Package ndc › 2 | 58151-504-91 |
| Openfda › Package ndc › 3 | 58151-505-91 |
| Openfda › Package ndc › 4 | 58151-506-91 |
| Openfda › Product ndc › 1 | 58151-503 |
| Openfda › Product ndc › 2 | 58151-504 |
| Openfda › Product ndc › 3 | 58151-505 |
| Openfda › Product ndc › 4 | 58151-506 |
| Openfda › Generic name | ALPRAZOLAM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Benzodiazepines [CS] |
| Openfda › Substance name | ALPRAZOLAM |
| Openfda › Pharm class epc | Benzodiazepine [EPC] |
| Openfda › Manufacturer name | Viatris Specialty LLC |
| Openfda › Application number | NDA021434 |
| Openfda › Is original packager | true |
| Event id | 98613 |
| Address 1 | 1000 Mylan Blvd |
| Code info | Lot# 8177156, Exp Date: 02/28/2027 |
| Postal code | 15317-5853 |
| Report date | 20260415 |
| Product type | Drugs |
| Reason for recall | Failed Dissolution Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260317 |
| Initial firm notification | Letter |
| Center classification date | 20260408 |
Overview
- Recalling FirmViatris, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.