Home Recalls D-0444-2026
Class II · Moderate risk Ongoing Initiated Mar 17, 2026 (6 months ago)
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
What was recalled
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
Recalling firm Viatris, Inc.
NDC code 58151-506-91
Origin PA, United States
Initiated by Voluntary: Firm initiated
FDA recall number D-0444-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
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Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
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Class II · Moderate risk Ongoing Mar 22, 2023
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk Ongoing Mar 22, 2023
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.