Seizure Medication Recalled Over Foreign Tablet Contamination

Amneal Pharmaceuticals LLC has initiated a voluntary recall of clobazam tablets, 10 mg, packaged in 30-tablet cartons (NDC 60687-423-21) distributed by American Health Packaging. The affected product, identified by lot number 1019594 with an expiration date of 12/31/2025, involves 5178 cartons distributed nationwide within the US. This recall was prompted by the detection of foreign tablets or capsules mixed within the blister packaging, posing a potential risk to patient safety. The recall process began on December 13, 2024, with notification to consignees via letter. The US Food and Drug Administration classified this as a Class II recall on January 6, 2025.

The recalling firm, Amerisource Health Services LLC, based in Columbus, Ohio, has emphasized the voluntary nature of the recall. Class II recalls are initiated when exposure to the product may cause temporary or medically reversible adverse health consequences or when there is a remote possibility of serious harm. While no public press release has been issued, the firm has advised stakeholders, including pharmacists and health care providers, to immediately review their inventories, segregate affected products, and contact Amerisource for further instructions.

Clobazam is a benzodiazepine indicated for managing seizures associated with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy. As a critical medication in seizure management, pharmacists must prioritize ensuring the integrity of the supply chain to safeguard patient health. Pharmacists should remain vigilant and promptly act to address this recall to minimize disruption to patient care.