BD Issues Nationwide Recall For Specific Lots Of ChloraPrep™ Clear Single Sterile 1 mL And FREPP™ Clear 1.5 mL Applicators Due To Microbial Contamination
FRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding to the consumer level. These products are being recalled due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.
These two impacted lots were shipped to distributors and hospitals between March 2024 through June 2024.
Risk Statement: Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death. If the fungus is introduced in the patient’s bloodstream during placement of an intravascular catheter, the catheter would most likely have to be removed, necessitating another procedure. Aspergillus penicillioides infection of a surgical site may result in the need for medical and surgical interventions and long-term treatment with antifungal drugs. Importantly, BD has not received any reports of adverse events related to this recall.