BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (I… recall
FDA recall D-0624-2026 · initiated May 28, 2026
CareFusion 213, LLC recalled BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… in May 2026 — an FDA Class I recall (D-0624-2026) because Non-Sterility: Due to presence of Aspergillus penicillioides.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Non-Sterility: Due to presence of Aspergillus penicillioides.
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: 193,440 applicators
Details
- Product
- BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
- Recalling company
- CareFusion 213, LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide inthe USA, as well as other foreign distribution.
- Initiated
- May 28, 2026
- FDA report date
- Jul 1, 2026
This recall is linked to a product we cover: Chloraprep One-Step →
Frequently asked
- Was BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… recalled?
- CareFusion 213, LLC recalled BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… in May 2026 — an FDA Class I recall (D-0624-2026) because Non-Sterility: Due to presence of Aspergillus penicillioides. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… recalled?
- Per the FDA enforcement record, the reason for recall D-0624-2026 was: Non-Sterility: Due to presence of Aspergillus penicillioides.
- Is a recalled BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… 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 (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… are affected?
- Distributed: Nationwide inthe USA, as well as other foreign distribution.. The recall covers these lots — Lot # 4032183, Exp 01/31/2027. 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-0624-2026.