On July 16, 2024, Endo, Inc announced a voluntary recall of one lot of clonazepam orally disintegrating 0.25 mg tablets. The product is being recalled due to mislabeling of the cartons where 0.25 mg tablets are labeled as 0.125 mg tablets. However, the blister strips inside the cartons reflect the correct strength of 0.25 mg. Clonazepam is indicated for the treatment of Lennox-Gastaut syndrome, akinetic and myoclonic seizures and panic disorder. Use of the mislabeled product could expose a patient to double the intended dose if they believe they are taking 0.125mg. Using higher doses of clonazepam increases the risk of significant sedation, dizziness, impaired coordination, confusion and respiratory depression.
The recalled clonazepam orally disintegrating tablets are packaged in cartons of 60 tablets. The impacted products are labeled with lot number 550147301. Endo is providing written notification to wholesalers and retailers to arrange for the return of the recalled lot. Consumers with the recalled products should immediately stop using them and contact their health care provider if any problems arise after use. Adverse effects should also be reported to the FDA’s MedWatch Adverse Event Reporting program. To date, Endo has not received any reports of adverse events related to this recall.