Xanax XR Tablets Recall Over Failed Dissolution Specifications
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Viatris Inc. is voluntarily recalling Xanax XR extended-release tablets due to failed dissolution specifications, affecting products distributed nationwide in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Viatris Inc. has initiated a voluntary recall of Xanax XR extended-release tablets because they failed dissolution specifications, which could impact the product's performance. This recall is classified as Class II by the FDA.
Which Products Are Affected
The affected product is Xanax XR, alprazolam extended-release tablets, 3 mg, in 60-tablet bottles. The NDC number is 58151-506-91, with UPC codes including 0358151506910. The lot number is 8177156, with an expiration date of February 28, 2027. Distribution was nationwide in the United States, and the product quantity is not specified in the recall details.
What You Should Do
Consumers should follow the initial firm notification, which was a letter, and contact Viatris Inc. for further instructions on returns or refunds. The recalling firm is Viatris Inc., located at 1000 Mylan Blvd, Canonsburg, PA 15317-5853.
Why This Matters
This recall highlights potential quality issues in prescription drugs that could affect patient safety and treatment efficacy. It underscores the importance of adhering to manufacturing standards to ensure reliable medication performance.
Source
This information is from the FDA recall database. Attribution: FDA Recall Number D-0444-2026. For more details, visit the FDA website at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.
Original source: FDA Official Notice ↗
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