Seizure Medication Recalled for Foreign Capsule Contamination
A voluntary Class II recall has been initiated for Clobazam Tablets, 10 mg, distributed by American Health Packaging and manufactured by Amneal Pharmaceuticals LLC. The recall affects 4640 units of product packaged in cartons of 30 tablets (3x10 blister cards). The issue prompting the recall is the presence of foreign tablets or capsules discovered in the packaging.
Clobazam is a prescription benzodiazepine indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of epilepsy. The affected lot is #1018598, with an expiration date of October 31, 2025. Distributed nationwide in the United States, the recall began on January 7, 2025, and remains ongoing.
The recalling firm, Amerisource Health Services LLC, headquartered in Columbus, Ohio, is managing the recall. The FDA classified this as a Class II recall on January 14, 2025, indicating that the product may cause temporary or medically reversible health issues, but serious health risks are less likely.
