CLASS II ONGOING Drug recall · Reported 15 Apr 2026 · FDA Enforcement Report
Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by Viatris
Viatris is recalling Xanax XR, alprazolam, extended-release tablets, 3 mg, distributed nationwide in the US. The recall was initiated on 17 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0444-2026
- FDA event ID
- 98613
- Recalling firm
- Viatris, Canonsburg, PA
- Brand
- Xanax
- Manufacturer
- Viatris Specialty LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Mar 2026
- FDA classified
- 8 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 17 Mar 2026 | Recall initiated by company | |
| 8 Apr 2026 | Classified by FDA | +22 days |
| 15 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot# 8177156, Exp Date: 02/28/2027
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Viatris
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 4 mg recalled by ViatrisCardura | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 8 mg recalled by ViatrisCardura | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 25 mcg recalled by ViatrisLevothyroxine Sodium | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 75 mcg recalled by ViatrisLevothyroxine Sodium | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 88 mcg recalled by ViatrisLevothyroxine Sodium | Viatris | Potency & Assay | Nationwide |
Other Alprazolam recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprazolam Tablets, USP, 2 mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP, 0.5mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP, 0.25mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP, 1 mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | alprazolam XR extended-release tablets, 3 mg recalled by ViatrisAlprazolam | Viatris | Potency & Assay | Nationwide |