BD Recalls Two Lots of ChloraPrep and FREPP Skin-Prep Applicators Over Aspergillus Fungal Contamination

Lot 4032183 of ChloraPrep 1 mL and Lot 4073005 of FREPP 1.5 mL were shipped nationwide between March and June 2024; fungal contamination poses serious infection risk, particularly for immunocompromised patients.

Becton, Dickinson and Company (BD) has issued a nationwide recall of two specific lots of its chlorhexidine-based skin antiseptic applicators after laboratory testing detected fungal contamination capable of causing life-threatening infection, the FDA announced June 6, 2026.

The recalled products are ChloraPrep Clear Single Sterile 1 mL applicators (Lot 4032183) and FREPP Clear 1.5 mL applicators with paper lidding (Lot 4073005). Both products contain chlorhexidine gluconate and are used to prepare the skin prior to surgery, catheter placement, and other invasive procedures — settings where microbial sterility is critical.

BD identified the contaminating organism as Aspergillus penicillioides, a mold that proliferates under certain environmental conditions. The FDA warns that contamination of a skin-preparation product with this fungus may lead to serious systemic infection, sepsis, and death. The risk is particularly acute for immunocompromised patients — including those undergoing chemotherapy, organ transplant recipients, and people with HIV — for whom invasive aspergillosis carries high mortality.

Both lots were distributed nationwide to hospitals and distributors between March 2024 and June 2024 — approximately 24 to 27 months before the recall announcement. No adverse events had been reported to BD at the time of the recall announcement, according to the FDA notice.

Healthcare facilities should immediately quarantine and discontinue use of any remaining stock from these lots and contact their BD representative to arrange return and replacement of affected units.

Note: The FDA recall classification for this action could not be confirmed directly from the FDA page at time of filing — editors should verify the classification field against the live FDA record at the URL cited above.

TopicsBD · FDA

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At the Agencies

BD ChloraPrep / FREPP — Nationwide Voluntary Recall — Aspergillus penicillioides contamination in specific lots of ChloraPrep 1 mL and FREPP 1.5 mL chlorhexidine skin-prep applicators; risk of sepsis and death in surgical patients; distributed to hospitals March-June 2024.

J&J Cerenovus CEREPAK — Class I Recall — Higher-than-expected failure-to-detach rate linked to four serious injuries and one death; risks include hemorrhagic/ischemic stroke; ~12,000 units across 11 product lines.

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