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The popular anxiety drug Clonazepam is being recalled nationwide due to a potentially life-threatening labeling mistake. The pharmaceutical company Endo Inc. announced the recall of 16 lots of Clonazepam Orally Disintegrating Tablets after it was discovered that the cartons were mislabeled with the incorrect strength and National Drug Code (NDC). The error was made by a third-party packager.
The recall affects tablets with doses ranging from 0.125 milligrams to 2 milligrams, due to expire between August 2026 and February 2027. The company advises patients to discontinue the use of the product and consult a physician if they inadvertently took an incorrect dose. More information, including the lot numbers impacted by the recall, can be found in a notice published by the FDA.
Clonazepam is a benzodiazepine used to treat panic disorder and certain types of seizures. The incorrect labeling could lead to patients taking incorrect dosages, which could result in significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. The FDA warned that there is a reasonable probability for significant, possibly life-threatening, respiratory depression, especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.
As of November 21, Endo Inc. reported that there have not been any adverse effects from the product recall.