Endo, Inc (OTCQX: NDOI) (“Endo”) has announced a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets. This recall, initiated by Endo USA, Inc., affects product cartons mislabelled as 0.125 mg tablets. The mislabeling occurred due to an error at a third-party packaging facility, while the blister strips inside the cartons correctly indicate the 0.25 mg strength.
Children and adults inadvertently prescribed a two-fold overdose of clonazepam are at risk for significant adverse effects, including sedation, dizziness, ataxia, and confusion. There is a reasonable probability of serious, potentially life-threatening respiratory depression, particularly for patients with underlying pulmonary disease or those taking other medications that depress respiration. Despite the mislabeling, no adverse events associated with this recall have been reported to date.
Product Details and Indications
Clonazepam Orally Disintegrating Tablets are indicated for use alone or as an adjunct in treating Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures, and panic disorder. The affected product is packaged in 60-count cartons and bears the lot number 550147301, with an expiration date of August 2026. The impacted units are identified by the National Drug Code (NDC) number 49884-307-02; however, the mislabeled cartons will display NDC 49884-306-02.
The recalled lot was distributed through wholesale distributors to retail pharmacies nationwide. Endo is notifying wholesale accounts and retailers that received the affected lot, arranging for the return of all existing inventory through Inmar, Inc. Distributors and retailers in possession of the recalled lot should immediately cease distribution and dispensing and return the products to the place of purchase or contact Inmar at 877-890-0765.
Instructions for Consumers
Consumers possessing any unused 60-tablet cartons of Clonazepam Orally Disintegrating Tablets, USP 0.25 mg, which may appear as 0.125 mg due to mislabeling, are advised to discontinue use immediately. Patients who have inadvertently taken a 0.25 mg dose instead of the intended 0.125 mg dose should consult their physician.
This product lot recall is being conducted with the knowledge of the FDA, ensuring adherence to regulatory requirements and maintaining consumer safety. Endo is a diversified specialty pharmaceutical company dedicated to transforming insights into life-enhancing therapies. The company’s passionate team collaborates to develop and deliver essential medicines, committed to helping everyone they serve live their best life.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including those related to the product lot recall, potential adverse events, and regulatory actions by the FDA. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plans,” “will,” “may,” “look forward,” “guidance,” “future,” “potential,” or similar expressions are forward-looking statements.
These statements reflect Endo’s current views, expectations, and beliefs concerning future events, and involve risks and uncertainties, some of which Endo may not currently predict. Although Endo believes that these forward-looking statements are based on reasonable assumptions and expectations, readers should not place undue reliance on them. Actual results may differ materially from current expectations based on various risks, uncertainties, and factors, including those related to the recall and any future recalls, potential adverse events, and regulatory actions by the FDA. Endo assumes no obligation to publicly update any forward-looking statements, whether due to new information, future developments, or otherwise, except as required by applicable securities laws.
Resource: U.S. Food and Drug Administration, July 17, 2024

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