Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.
Viatris has recalled one batch of the anti-anxiety medicine Xanax XR in the U.S. because it failed a test of the rate and extent of drug release.
The company voluntarily initiated the recall after a batch of bottles containing 60 3-mg tablets of the drug failed dissolution specifications. Drugmakers run dissolution tests to assess the conversion of oral dosage forms into solutions. That conversion determines the bioavailability of the active ingredient and thereby affects the efficacy of the drug product.
Viatris found that the dissolution of a batch of extended-release Xanax manufactured in Ireland diverged from the specifications, triggering the Class II recall. The news comes four years after Viatris pulled 110 bottles of Xanax XR from the U.S. market because of out-of-specification results for dissolution. Pfizer, which used to own the drug, recalled 36,000 bottles of immediate-release Xanax in 2012 over dissolution test results.
The FDA approved Xanax XR in 2003, months before Pfizer acquired the asset as part of its $60 billion takeover of Pharmacia. An immediate-release formulation of the active ingredient, the benzodiazepine alprazolam, was already available. However, the older product needed to be taken three to four times a day. Xanax XR is taken once daily.
Alprazolam was off patent and facing generic competition when the FDA approved Xanax XR. Supported by the extended-release formulation, Pfizer grew sales of its Xanax franchise to $350 million in 2008. By then, generic extended-release alprazolam products were competing for market share.
Actavis launched a generic copy of the drug in 2007. Impax Laboratories, which is now part of Amneal Pharmaceuticals, entered the market months after Actavis. Aurobindo Pharma’s generic won FDA approval in 2011.
Xanax XR was part of Pfizer until the drugmaker merged its Upjohn business with Mylan to form Viatris in 2020. Viatris reported $139.9 million in Xanax sales last year. Sales have slipped in recent years, falling from $154.8 million in 2023 to $145 million in 2024.
Viatris’ Xanax XR withdrawal was one of 30 drug recalls in the FDA’s latest weekly enforcement report, which also included five recalls by Teva Pharmaceuticals. The company withdrew about 30,000 packages of the acne medicine isotretinoin across two recalls because they were superpotent or subpotent. Teva recalled isotretinoin in January, but the FDA only classified the action this month.
Teva’s three other recalls stemmed from the use of an unapproved raw material. The FDA listed Actavis Laboratories as the manufacturer of the recalled batches of Teva’s clonidine transdermal system.
