Viatris Initiates Xanax XR Recall, Class II
Summary
Viatris Specialty LLC has initiated a Class II drug recall for one lot of Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-tablet bottles, due to Failed Dissolution Specifications. Affected lot #8177156 (Exp 02/28/2027, NDC 58151-506-91) was distributed US Nationwide. The recall was firm-initiated on March 17, 2026 and classified by FDA as Class II on April 8, 2026. A Class II recall indicates possible temporary or reversible health consequences or where the probability of serious adverse health consequences is remote.
What changed
Viatris Specialty LLC initiated a voluntary Class II recall for one lot of Xanax XR (alprazolam) extended-release 3mg tablets distributed in 60-tablet bottles (NDC 58151-506-91, Lot #8177156, Exp 02/28/2027). The recall was triggered by failed dissolution specifications, meaning the tablets may not dissolve within acceptable parameters, potentially affecting drug absorption and therapeutic effect. FDA classified the recall on April 8, 2026 as Class II, indicating possible temporary or reversible health consequences or remote probability of serious adverse health consequences.
Healthcare providers, pharmacies, and patients in possession of Lot #8177156 should verify stock and follow the firm's notification instructions (letter). Any adverse events associated with tablets from this lot should be reported to FDA MedWatch. Pharmacies and distributors should check inventory systems against the affected lot number and take appropriate action per the recall communication.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Viatris, Inc.
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0444-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
Reason for Recall
Failed Dissolution Specifications
Affected Lot Numbers / Codes
Lot# 8177156, Exp Date: 02/28/2027
Firm Notification Method
Letter
Distribution
US Nationwide.
Initiated
20260317
FDA Classified
20260408
Product Registration
Brand: XANAX
Generic: ALPRAZOLAM
Manufacturer: Viatris Specialty LLC
Application: NDA021434
NDC: 58151-503, 58151-504, 58151-505
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Boxed Warning
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . • The use of benzodiazepines, including XANAX XR, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol,...
Indications & Usage
1 INDICATIONS AND USAGE XANAX XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults. XANAX XR is a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended starting oral dosage is 0.5 mg to 1 mg once daily (preferably in the morning). Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg daily. ( 2.1 ) • Recommended total daily dosage is 3 mg to 6 mg daily. ( 2.1 ) • Swallow tablets whole; do not divide, crush, or chew. ( 2.1 ) • When tapering, decrease dosage by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. ( 2.2 , 5.2 ) • See the Full Prescribing Information for the recommended dosage in geria...
Contraindications
4 CONTRAINDICATIONS XANAX XR is contraindicated in patients: • with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions (6.2) ] . • taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.5) , Warnings and Precautions (5.5) , Drug Interactions (7.1) ] . • Known hypersensitivity to alprazolam or other benzodiazepines. ( 4 ) • Concomitant use with str...
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] • Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2) ] • Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3) ] • Effects on Driving and Operating Machinery [see Warnings and Precautions (5.4) ] • Patients with Depression [see Warnings and Precautions (5.7) ] • Neonat...
Drug Interactions
7 DRUG INTERACTIONS • Use with Opioids: Increase the risk of respiratory depression. ( 7.1 ) • Use with Other CNS Depressants: Produces additive CNS depressant effects. ( 7.1 ) • Use with Digoxin: Increase the risk of digoxin toxicity. ( 7.1 ) • Use with CYP3A Inhibitors (except ritonavir): Increase the risk of adverse reactions of alprazolam. ( 4 , 5.5 , 7.1 ) • Use with CYP3A Inducers: Increase the risk of reduced efficacy of alprazolam. ( 7.1 ) 7.1 Drugs Having Clinically Important Interac...
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING XANAX XR is supplied in the following strengths and package configurations: XANAX XR Tablets Package Configuration Tablet Strength (mg) NDC Print Bottles of 60 0.5 mg NDC 58151-503-91 white, pentagonal shaped tablets debossed with an "X" on one side and "0.5" on the other side Bottles of 60 1 mg NDC 58151-504-91 yellow, square shaped tablets debossed with an...
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