Viatris recalls 3mg Xanax XR tablets with failed dissolution specs. This may affect medication effectiveness. Check NDC 0009-0068-07 and lot DX7983 for affected products.
“Viatris Xanax XR 3mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/34807-viatris-xanax-xr-3mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0854-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0854-2022%22&limit=1).
Viatris Inc voluntarily recalled Xanax XR (alprazolam) extended-release tablets due to failed dissolution specifications, according to the FDA. The Food and Drug Administration announced the Class II recall on April 28, 2022.
Distributed by: Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017
The hazard
The recall addresses low out-of-specification results for dissolution in the extended-release tablets. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Viatris, Inc. has had 10 other recalls on record since April 28, 2022. Other recent recalls of similar products include Supernus Trokendi XR 50mg Capsules (August 31, 2026), Teva Metoprolol Succinate Tablets (January 29, 2026), and Teva Metoprolol Succinate Extended-Release Tablets (January 29, 2026).
How to tell if you have this one
Check for the NDC code 0009-0068-07 and lot number DX7983 on the product label. These tablets are prescription-only and distributed by Pharmacia & Upjohn Co.
Brand
Viatris
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for NDC 0009-0068-07 and lot number DX7983 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0854-2022 (April 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0854-2022 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.