FDA recall, , Moderate risk
Viatris Xanax XR Extended-Release Tablets
Xanax XR extended-release tablets failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
Viatris, Inc., of Canonsburg, Pennsylvania, recalled Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, distributed by Viatris Specialty LLC, Morgantown, WV, because the product failed dissolution specifications. The recall began on March 17, 2026, and the product was distributed nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles
- NDC
- 58151-506-91
- Lot code
- 8177156
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Viatris, Inc.Canonsburg, Pennsylvania
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98613
- Recall number
- D-0444-2026
All recalls from Viatris, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
