CLASS II ONGOING Drug recall · Reported 28 May 2025 · FDA Enforcement Report
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate recalled
CareFusion 213 is recalling BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol, distributed nationwide in the US. The recall was initiated on 15 May 2025 and the FDA has classified it as Class II.
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-0441-2025
- FDA event ID
- 96879
- Recalling firm
- CareFusion 213, El Paso, TX
- Brand
- Chloraprep One-step
- Manufacturer
- CareFusion 213, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 May 2025
- FDA classified
- 20 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 15 May 2025 | Recall initiated by company | |
| 20 May 2025 | Classified by FDA | +5 days |
| 28 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
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 Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol recalled?
Yes. CareFusion 213 recalled BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol on 15 May 2025. The recall is Class II and its status is Ongoing. Recall number D-0441-2025.
Why was it recalled?
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Which lots are affected?
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Where was it sold?
Nationwide in the U.S.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Sterility | 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 |