CLONAZEPAM has been recalled due to potential product carton strength mislabeling. Endo Pharmaceuticals (Malvern, Pennsylvania) has issued a voluntary, nationwide recall of a specific lot of Clonazepam Orally Disintegrating Tablets (USP, C-IV). The cartons inaccurately list the tablet strength as 0.125 mg instead of the correct 0.25 mg. This error occurred during packaging by a third-party vendor. While the blister packs inside display the accurate dosage, the labeling discrepancy poses a significant risk to patient safety, particularly for those prescribed a lower dose.
Clonazepam is widely used to treat seizures, panic disorders, and other conditions. A double dosage could result in severe side effects such as excessive sedation, confusion, ataxia, and in extreme cases, life-threatening respiratory depression, especially in vulnerable patients such as those with pulmonary conditions or on medications that enhance respiratory suppression.
Endo has reported no adverse events linked to this issue so far. Distributed nationwide to pharmacies, the affected lot carries an expiration date of August 2026. Healthcare providers have been urged to halt dispensing this lot immediately and return the product. Patients are being advised to consult their healthcare providers to confirm proper dosing.
Reference: FDA. Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling. November 19, 2024. Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential#recall-announcement. Last accessed: November 26, 2024.
