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Lower risk Drug recall · FDA · Published March 17, 2026

Viatris Xanax XR 3mg Tablets Recall: Failed Dissolution Specifications

Viatris recalls 3mg Xanax XR tablets with failed dissolution specs. This may affect medication effectiveness. Contact Viatris for details.

🇺🇸 FDA recall #D-0444-2026DrugViatris ›
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Recalling firmViatris, Inc.1000 Mylan Blvd · Canonsburg, PA 15317-5853
✎ GovInfoNow plain-language explainer

Viatris is recalling 3mg Xanax XR tablets that failed dissolution tests. This could mean the medication doesn't work as intended, which is serious for people taking it for anxiety or seizures. Read more at govinfonow.com/recall/31427-viatris-xanax-xr-3mg-tablets-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/31427-viatris-xanax-xr-3mg-tablets-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0444-2026

Cite this page

“Viatris Xanax XR 3mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31427-viatris-xanax-xr-3mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0444-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0444-2026%22&limit=1).

The FDA announced on March 17, 2026, that Viatris, Inc. is recalling Xanax XR extended-release tablets due to failed dissolution specifications. The recall affects 3 mg bottles distributed nationwide.

How to tell if you have it

  • Brand: Viatris
  • Product: Xanax XR, alprazolam, extended-release tablets
  • Strength/Size: 3 mg, 60 Tablets bottles
  • NDC: 58151-506-91
  • Lot Code: 8177156
  • Expiration Date: 02/28/2027
  • Distributor: Viatris Specialty LLC

The hazard

The recalled Xanax XR tablets have failed dissolution specifications. The FDA classified this recall as Class II.

Context

GovInfoNow's records show Viatris, Inc. has had 10 other recalls since April 28, 2022. Recent similar recalls include Teva Metoprolol Succinate Tablets (Jan. 29, 2026), Supernus Trokendi XR Capsules (Aug. 31, 2026), and Novartis Diovan Tablets (Aug. 4, 2026) due to failed dissolution specifications. Public reports indicate 204,830 adverse-event reports in the FDA's FAERS database naming this product, with 144,779 marked serious and 33,445 listing a death.

How to tell if you have this one

Check for the product name 'Xanax XR', 3mg tablets, 60-count bottles, with lot number 8177156 and expiration date 02/28/2027. This product is prescription-only and distributed by Viatris Specialty.

  • Brand
    Viatris
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 8177156 and expiration date 02/28/2027 on the bottle.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

1. Firm started the recall: Mar 17, 202612. FDA classified it Class II: Apr 8, 202623. Published in FDA’s Enforcement Report: Apr 15, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0444-2026 (March 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0444-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA