BD ChloraPrep Clear 1mL Applicators recall
FDA recall D-0259-2025 · initiated Feb 14, 2025
CareFusion 213, LLC recalled BD ChloraPrep Clear 1mL Applicators in Feb 2025 — an FDA Class I recall (D-0259-2025) because Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 205,440 applicators
Details
- Product
- BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
- Recalling company
- CareFusion 213, LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide and Canada
- Initiated
- Feb 14, 2025
- FDA report date
- Mar 19, 2025
This recall is linked to a product we cover: Chloraprep One-Step →
Frequently asked
- Was BD ChloraPrep Clear 1mL Applicators recalled?
- CareFusion 213, LLC recalled BD ChloraPrep Clear 1mL Applicators in Feb 2025 — an FDA Class I recall (D-0259-2025) because Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was BD ChloraPrep Clear 1mL Applicators recalled?
- Per the FDA enforcement record, the reason for recall D-0259-2025 was: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
- Is a recalled BD ChloraPrep Clear 1mL Applicators dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of BD ChloraPrep Clear 1mL Applicators are affected?
- Distributed: Nationwide and Canada. The recall covers these lots — Lot #: 3200240, Exp 6/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0259-2025.