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GMJ News > GMJ Briefs > BD Recalls ChloraPrep and FREPP Applicators Due to Fungal Contamination
Pharmacy & PrescribingPractice

BD Recalls ChloraPrep and FREPP Applicators Due to Fungal Contamination

GMJ
Last updated: 12/06/2026 02:54
By
Prof. Giorgi Pkhakadze
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✓ Editorially Reviewed by Prof. Giorgi Pkhakadze, MD, MPH, PhD — GMJ News Desk

BD (Becton, Dickinson and Company) has issued a voluntary nationwide recall of specific lots of ChloraPrep™ Clear and FREPP™ Clear antiseptic applicators due to fungal contamination, the FDA announced on June 6, 2026. The recall affects lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile applicators and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding.

Key takeaways

  • Two specific lots of BD antiseptic applicators recalled due to fungal contamination
  • Recall affects ChloraPrep™ Clear 1 mL (lot 4032183) and FREPP™ Clear 1.5 mL (lot 4073005) applicators
  • Products recalled to consumer level due to infection risk concerns
2 lots
of BD antiseptic applicators recalled nationwide due to fungal contamination

Contaminated Products Identified

The recall specifically targets lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile applicators and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding. BD initiated this voluntary recall after identifying fungal contamination in these specific production lots.

These antiseptic applicators are commonly used in healthcare settings for skin preparation before medical procedures. The FDA’s recall database shows this as a consumer-level recall, indicating the potential for serious health consequences.

Healthcare Safety Implications

Fungal contamination in antiseptic products poses significant infection risks, particularly for immunocompromised patients or those undergoing invasive procedures. Healthcare facilities using these products should immediately check their inventory for the affected lot numbers.

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The recall extends to the consumer level, indicating the FDA and BD consider the contamination risk serious enough to warrant comprehensive product removal from all distribution channels. Healthcare professionals should review their quality and safety protocols for antiseptic product verification.

BD voluntarily recalled two specific lots of antiseptic applicators due to fungal contamination, with products recalled to the consumer level due to infection risk concerns.

— FDA Safety Alert, June 2026

What this means

For patients: If you have these products at home, stop using them immediately and contact your healthcare provider if you’ve recently used them and experience signs of infection
For clinicians: Check inventory immediately for affected lot numbers, implement additional antiseptic verification protocols, and monitor patients who received these products for signs of infection
For policymakers: Review antiseptic product quality control standards and consider enhanced monitoring requirements for critical sterile medical devices

Frequently asked questions

Which specific products are being recalled?

The recall affects lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile applicators and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding. Only these specific lot numbers are included in the recall.

What should healthcare facilities do with these products?

Healthcare facilities should immediately stop using products from the affected lots and check their inventory for these specific lot numbers. Contact BD or your distributor for product return and replacement procedures.

What are the health risks from using contaminated antiseptic applicators?

Fungal contamination in antiseptic products can lead to serious infections, particularly in immunocompromised patients or during invasive procedures. The contamination defeats the antiseptic’s intended protective function.

Healthcare facilities and providers should immediately discontinue use of the affected lots and implement enhanced verification procedures for antiseptic products. The recall underscores the critical importance of sterile product integrity in preventing healthcare-associated infections, particularly as pharmaceutical safety standards continue to evolve in response to emerging contamination risks.

Source: 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

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TAGGED:BD recallChloraPrepFDA safety alertFREPPfungal contamination
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ByProf. Giorgi Pkhakadze
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Prof. Giorgi Pkhakadze, MD, MPH, PhD, is Editor-in-Chief of the Georgian Medical Journal and Chair of the Public Health Institute of Georgia (PHIG). He is Professor and Head of the Department of Social and Behavioural Sciences at David Tvildiani Medical University, and Secretary/Treasurer of the UEMS Section of Public Health. ORCID: 0000-0001-7609-4515.

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