BD ChloraPrep FREPP Clear recall
FDA recall D-0625-2026 · initiated May 28, 2026
CareFusion 213, LLC recalled BD ChloraPrep FREPP Clear in May 2026 — an FDA Class I recall (D-0625-2026) because Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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: 178,000 applicators
Details
- Product
- BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
- 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 FREPP Clear recalled?
- CareFusion 213, LLC recalled BD ChloraPrep FREPP Clear in May 2026 — an FDA Class I recall (D-0625-2026) because Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was BD ChloraPrep FREPP Clear recalled?
- Per the FDA enforcement record, the reason for recall D-0625-2026 was: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- Is a recalled BD ChloraPrep FREPP Clear 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 FREPP Clear are affected?
- Distributed: Nationwide inthe USA, as well as other foreign distribution.. The recall covers these lots — Lot # 4073005, Exp 03/31/2027. 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-0625-2026.