The FDA has classified a Class II drug recall (D-0360-2026) for Dukal BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) manufactured for Dukal, LLC. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The product was distributed nationwide.

Drug manufacturers and distributors involved in the supply chain must ensure they have processes in place to identify and manage recalled products. While this is a Class II recall, indicating that use or exposure may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote, entities should review their CGMP compliance and recall procedures. No specific compliance deadline is mentioned, but the recall is ongoing.