Endo Inc. has expanded its recall of Clonazepam Orally Disintegrating Tablets, USP, due to potential mislabeling of product strength on its packaging, the U.S. Food and Drug Administration (FDA) announced on November 19. The issue could lead to incorrect dosing, posing a significant risk of severe side effects, including life-threatening respiratory depression.
The recall stems from an investigation revealing that some cartons may have incorrect strength labels and National Drug Codes (NDC), attributed to errors by a third-party packager. The affected lots, distributed to retail pharmacies across the United States, include 60-tablet packages divided into 10 blister strips.
According to the FDA, higher-than-prescribed doses of clonazepam can result in sedation, confusion, dizziness, diminished reflexes, and hypotonia. Patients with pulmonary disease or those taking other respiratory-depressing medications are especially vulnerable. Despite these risks, Endo has not received reports of adverse reactions related to the recall.
Consumers are urged to stop using the recalled product and consult a physician if an incorrect dose was consumed. Wholesalers and pharmacies have been directed to halt distribution and dispensing immediately.
Clonazepam, a benzodiazepine marketed under the brand name Klonopin and generics, is commonly prescribed for anxiety, seizures, panic disorders, and obsessive-compulsive disorder. It ranked as the 57th most prescribed medication in the United States in 2022, with more than 11.7 million prescriptions, according to ClinCalc.
The recalled NDCs are:
- Clonazepam ODT, USP (C-IV) 2mg: 49884-310-02
- Clonazepam ODT, USP (C-IV) 0.125mg: 49884-306-02
- Clonazepam ODT, USP (C-IV) 0.25mg: 49884-307-02
- Clonazepam ODT, USP (C-IV) 1mg: 49884-309-02
For additional details, including lot numbers and expiration dates, visit the FDA’s website.
