Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distrib… recall
FDA recall D-0444-2026 · initiated Mar 17, 2026
Viatris, Inc. recalled Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl… in Mar 2026 — an FDA Class II recall (D-0444-2026) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- 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 company
- Viatris
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Mar 17, 2026
- FDA report date
- Apr 15, 2026
This recall is linked to a product we cover: Xanax XR →
Frequently asked
- Was Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl… recalled?
- Viatris, Inc. recalled Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl… in Mar 2026 — an FDA Class II recall (D-0444-2026) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl… recalled?
- Per the FDA enforcement record, the reason for recall D-0444-2026 was: Failed Dissolution Specifications
- Is a recalled Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl… are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot# 8177156, Exp Date: 02/28/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0444-2026.