Xanax XR 3 mg extended-release tablets fail dissolution specifications
Viatris is recalling one lot of Xanax XR (alprazolam) extended-release tablets, 3 mg, after the product failed dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a failed dissolution specification, which can alter the rate of drug release and creates a risk of harm with no injuries reported.
Plain-English summary
Viatris, Inc. is recalling Xanax XR (alprazolam) extended-release tablets, 3 mg, supplied in bottles of 60 tablets, NDC 58151-506-91.
The stated reason is failed dissolution specifications. Dissolution testing measures how a tablet releases its active ingredient, and an extended-release formulation that falls outside specification may not deliver the drug at the intended rate. The FDA classified the action as Class II.
The affected lot is 8177156, expiry 02/28/2027. Distribution was US nationwide.
This is a prescription medicine. Patients should not stop taking a prescribed benzodiazepine without medical advice; anyone holding the affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- XANAX (ALPRAZOLAM)
- Brand
- XANAX
- Manufacturer
- Viatris, Inc.
- Category
- Drug — Extended-release tablet
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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