Xanax XR Extended-Release Tablets Recalled for Failed Dissolution Specifications
Viatris Inc. recalls Xanax XR (alprazolam) 3 mg extended-release tablets due to failed dissolution specifications. Affected lot 8177156 (exp. 02/28/2027) was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for pharmaceutical quality defect. Failed dissolution specifications affect medication bioavailability and efficacy. No illnesses or injuries reported in source material. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Viatris Inc. is recalling Xanax XR (alprazolam) 3 mg extended-release tablets in 60-tablet bottles due to failed dissolution specifications. The affected lot number is 8177156, with an expiration date of February 28, 2027. This product was distributed nationwide in the United States.
Patients who have received medication from the recalled lot are advised to contact their pharmacy or healthcare provider to determine whether their supply is affected. Further guidance on management of affected medication should be obtained from a healthcare provider or pharmacist.
The recalled product
- Product
- XANAX (ALPRAZOLAM)
- Brand
- XANAX
- Manufacturer
- Viatris, Inc.
- Category
- Drug — Benzodiazepine
- Hazard
- failed-dissolution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 8177156
- Exp Date: 02/28/2027
UPCs (4)
- 0358151506910
- 0358151504916
- 0358151503919
- 0358151505913
Distribution
Distributed nationwide across the United States.
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