BD ChloraPrep Clear 2% Recall: Sterility Concern
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was BD ChloraPrep Clear 2% recalled?
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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.
Which lot codes, UPCs or models are affected?
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
- Agency record number
- D-0441-2025
- Product
- BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile…
- Recalling firm
- CareFusion 213, LLC
- Quantity
- 385,200 applicators
- Distribution
- Nationwide in the U.S.
- Recall started
- May 15, 2025
- Report date
- May 28, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)