CLASS I ONGOING Drug recall · Reported 1 Jul 2026 · FDA Enforcement Report
BD ChloraPrep Frepp Clear,(2% w/v chlorhexidine gluconate recalled
CareFusion 213 is recalling BD ChloraPrep Frepp Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl, distributed nationwide in the US. The recall was initiated on 28 May 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0625-2026
- FDA event ID
- 99114
- Recalling firm
- CareFusion 213, El Paso, TX
- Brand
- Chloraprep One-step
- Manufacturer
- CareFusion 213, LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 May 2026
- FDA classified
- 25 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 28 May 2026 | Recall initiated by company | |
| 25 Jun 2026 | Classified by FDA | +28 days |
| 1 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide inthe USA, as well as other foreign distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # 4073005, Exp 03/31/2027
Where was it sold?
Nationwide inthe USA, as well as other foreign distribution.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99114This product is part of a recall event; the main page for the event is BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide | |
| CLASS II | BD ChloraPrep Frepp Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide | |
| CLASS I | BD ChloraPrep Clear (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
More recalls from CareFusion 213
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
Other Chlorhexidine Gluconate recalls
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Other | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |