FDA Recall: BD ChloraPrep & FREPP Skin-Prep Applicators Over Fungal Contamination Risk
Immediate action required — BD (Becton, Dickinson and Company) has initiated a nationwide recall of select BD ChloraPrep Clear and BD ChloraPrep FREPP Clear single-use skin-preparation applicators after quality testing detected the potential for Aspergillus penicillioides growth under certain storage conditions. Hospitals, clinics, distributors and consumers should stop using and destroy the lots listed below.
Why BD ChloraPrep & FREPP Were Recalled
The manufacturer’s routine microbial monitoring revealed possible fungal contamination. If a contaminated applicator contacts a patient’s bloodstream or surgical site, it can lead to severe invasive Aspergillus infections, sepsis, extended hospitalization or death. Although no injuries have been reported, both BD and the U.S. Food & Drug Administration (FDA) state the health risk is unacceptable.
BD ChloraPrep & FREPP: Impacted Lot Numbers
| NDC | Product | Catalog # | Lot # | Expiry | Package Size |
|---|---|---|---|---|---|
| 54365-400-31 | BD ChloraPrep Clear 1 mL Applicators | 930480 | 4032183 | 01/31/2027 | 60 applicators/carton |
| 54365-400-30 | BD ChloraPrep FREPP Clear 1.5 mL Applicators | 930299 | 4073005 | 03/31/2027 | 20 applicators/carton |
Additional catalog numbers are being withdrawn “out of an abundance of caution.” Full details appear in BD’s official customer letter.
Primary Recall Sources
BD ChloraPrep Recall: What Consumers & Healthcare Facilities Should Do
- Locate the catalog and lot numbers printed on the pouch lid or box side panel.
- Immediately discontinue use of recalled applicators.
- Quarantine and destroy affected inventory per facility protocol.
- Complete and return the BD Customer Response Form to receive free replacement product (for purchases made directly from BD).
- Report adverse reactions to the BD North American Regional Complaint Center at 1-844-823-5433 or productcomplaints@bd.com.
- Submit adverse events to FDA MedWatch online (fda.gov/medwatch/report.htm) or by calling 1-800-FDA-1088.
BD ChloraPrep Recall Timeline
- 06 Jun 2026: BD announces the voluntary recall to customers.
- 08 Jun 2026: FDA posts the company announcement publicly.
- Mar – Jun 2024: Distribution window for the affected lots.
BD Contact Information
BD North American Regional Complaint Center
Phone: 1-844-823-5433 (Mon–Fri, 8 a.m.–5 p.m. CT)
Email: productcomplaints@bd.com
Frequently Asked Questions
BD ChloraPrep & FREPP Recall FAQ
- 1. Which BD ChloraPrep products are affected by this recall?
- The recall covers BD ChloraPrep Clear 1 mL applicators (lot 4032183) and BD ChloraPrep FREPP Clear 1.5 mL applicators (lot 4073005) plus additional lots in the BD customer letter.
- 2. Where can I find the lot number on my BD ChloraPrep applicator?
- The lot number is printed on the paper lidding of each sterile pouch and on the side panel of every inner carton.
- 3. Can I safely use any remaining BD ChloraPrep or FREPP applicators?
- No. BD and the FDA instruct users to stop using and destroy all units from the recalled lots.
- 4. Will BD replace recalled BD ChloraPrep products that I destroy?
- Yes. Customers who purchased directly from BD can obtain free replacements by submitting the completed Customer Response Form.
- 5. What symptoms signal a possible BD ChloraPrep–related Aspergillus infection?
- Watch for fever, chills, redness or swelling at the catheter or surgical site, and other signs of systemic infection. Seek immediate medical care if symptoms occur.
- 6. How should facilities document disposal of BD ChloraPrep applicators?
- Facilities should follow internal biohazard disposal protocols, note the quantity destroyed, and retain copies of the BD Customer Response Form for audit purposes.
- 7. Does the BD ChloraPrep recall affect international customers?
- This recall is specific to the United States, but BD advises international partners to review inventory and follow local regulatory guidance.