BD ChloraPrep Clear recall
FDA recall D-0441-2025 · initiated May 15, 2025
CareFusion 213, LLC recalled BD ChloraPrep Clear in May 2025 — an FDA Class II recall (D-0441-2025) because Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
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: 385,200 applicators
Details
- Product
- 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.
- Recalling company
- CareFusion 213, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.
- Initiated
- May 15, 2025
- FDA report date
- May 28, 2025
This recall is linked to a product we cover: Chloraprep One-Step →
Frequently asked
- Was BD ChloraPrep Clear recalled?
- CareFusion 213, LLC recalled BD ChloraPrep Clear in May 2025 — an FDA Class II recall (D-0441-2025) because Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was BD ChloraPrep Clear recalled?
- Per the FDA enforcement record, the reason for recall D-0441-2025 was: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
- Is a recalled BD ChloraPrep 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 are affected?
- Distributed: Nationwide in the U.S.. The recall covers these lots — Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026. 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-0441-2025.