The U.S. Food and Drug Administration (FDA) has recently announced separate recalls initiated by Viatris and Teva Pharmaceutical Industries. Both actions were designated as Class II recalls, indicating that while the products may cause temporary or reversible adverse health effects, the probability of serious clinical consequences is remote.
Recall Specifications:
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Viatris (Anxiety Medication): The drugmaker is pulling one lot of extended-release Xanax tablets (3-mg strength). The recall was triggered by failed dissolution specifications, which affects how the medication breaks down to release its active ingredients into the patient’s system. The affected batch was manufactured in Ireland and distributed across the U.S., with an expiration date of February 2027.
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Teva (Hypertension Patch): The hybrid manufacturer is withdrawing multiple lots of its clonidine transdermal system (0.1, 0.2, and 0.3-mg/day dosages). Primarily used for high blood pressure, this patch is also prescribed off-label for ADHD and anxiety. The recall stems from manufacturing deviations involving the use of an “unapproved raw material.” Technical reports noted a lack of extractable and leachable data for this material to fully establish the product’s safety profile.
Risk Assessment: Despite the regulatory breaches regarding unapproved materials and dissolution failures, toxicological evaluations by both the companies and the FDA concluded that the overall risk of serious harm to patients is negligible. These recalls were initiated in mid-March 2026 and remain ongoing to ensure the removal of suspect batches from the supply chain.