According to the FDA, a voluntary recall of one lot of Xanax XR tablets was initiated by Viatris Inc. The recall was later designated as a Class II event.
The medicine was recalled because the affected lot failed "dissolution specifications," a manufacturing quality standard that measures how a drug releases its active ingredient in the body.
According to FDA guidance, failure to meet these specifications can affect the consistency and effectiveness of a medication's absorption.
The recall applies to lot No. 8177156 of 3-milligram extended-release tablets packaged in 60-count bottles. The product carries National Drug Code 58151-506-91 and an expiration date of Feb. 28, 2027. The FDA notice did not specify how many bottles or tablets are included in the recall.
The medication is distributed in the United States by Viatris Specialty LLC in Morgantown, West Virginia, and was manufactured in Ireland, according to FDA records. Medication distribution was nationwide, the FDA said.
The FDA noted that the recall was firm-initiated and that initial notification was made directly to consignees by letter, not through a public announcement. Such recalls are often communicated first to distributors, pharmacies, or health care providers.
The recall was initiated on March 17 and classified by the FDA on April 8, according to the FDA. The recall remains ongoing.
While companies may begin removing products from distribution earlier, recalls typically become visible to the public after the FDA completes its classification and publishes them in its weekly enforcement report.
The FDA also advises patients to first check the lot number on their medication bottle—typically found near the expiration date—and compare it to listings in the agency's recall database.