MALVERN, PA — Endo, Inc. (OTCQX: NDOI) has announced a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg. The recall affects tablets that may be incorrectly labeled as 0.125 mg. This mislabeling error occurred at a third-party packaging facility and could lead to a two-fold overdose.
The recall targets lot number 550147301, with an expiration date of August 2026. These tablets were distributed nationwide to retail pharmacies via wholesale distributors. The company has confirmed that the blister strips inside the cartons correctly display the 0.25 mg strength.
Taking a higher dose of clonazepam could result in severe side effects such as significant sedation, dizziness, ataxia, and confusion. For patients with respiratory issues or those on high doses, the risk of life-threatening respiratory depression increases. No adverse events related to this lot have been reported to date.
Clonazepam is used to treat various seizure disorders and panic attacks. The affected product is packaged in cartons of 60 tablets. Endo has initiated written notifications to wholesalers and retailers to return any remaining stock through Inmar, Inc.
Consumers possessing these tablets should stop using them immediately and consult their physician if an incorrect dose was taken. For more information, consumers can contact Inmar at 877-890-0765 or via email at rxrecalls@inmar.com.
This recall is conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Adverse reactions can be reported to the FDA’s MedWatch program online or by mailing in Form FDA 3500.
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