The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of Clobazam Tablets, 10 mg, after the discovery of foreign tablets or capsules mixed within the product packaging.
The recall was voluntarily initiated by Amerisource Health Services LLC on December 13, 2024, and involves 5,178 cartons of medication distributed across the United States.
Clobazam, a prescription drug used to treat seizures associated with Lennox-Gastaut syndrome, is critical for managing epilepsy.
The affected product is packaged in 30-tablet cartons (three blister cards of 10 tablets each) and distributed by American Health Packaging, with National Drug Code (NDC) 60687-423-21.
The recall specifically targets Lot Number 1019594, which carries an expiration date of December 31, 2025.
The FDA classified the recall as a Class II event on January 6, 2025, indicating that exposure to the defective product may cause temporary or medically reversible adverse health consequences.
While the risk is moderate, the presence of foreign capsules or tablets poses significant safety concerns, particularly for patients with underlying conditions or sensitivities to unintended medications.
Amerisource Health Services LLC, based in Columbus, Ohio, notified its consignees through letters. However, no public press release has been issued at this time.
Consumers and healthcare professionals are advised to check their supplies for the affected lot and discontinue use immediately. Patients should contact their healthcare provider for guidance on alternative treatment options.
For further details, consumers can refer to the FDA’s enforcement report at FDA Enforcement Report.