BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG) recall
FDA recall D-0243-2026 · initiated Dec 17, 2025
CareFusion 213, LLC recalled BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG) in Dec 2025 — an FDA Class II recall (D-0243-2026) because Lack of Assurance of Sterlity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterlity
Another quality failure
A quality failure that does not fit the categories above.
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: 106,400 units
Details
- Product
- BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
- Recalling company
- CareFusion 213, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Dec 17, 2025
- FDA report date
- Jan 7, 2026
This recall is linked to a product we cover: Chloraprep One-Step Sepp →
Frequently asked
- Was BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG) recalled?
- CareFusion 213, LLC recalled BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG) in Dec 2025 — an FDA Class II recall (D-0243-2026) because Lack of Assurance of Sterlity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG) recalled?
- Per the FDA enforcement record, the reason for recall D-0243-2026 was: Lack of Assurance of Sterlity
- Is a recalled BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG) 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" Triple Swabsticks (Chlorhexidine gluconate (CHG) are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 5086623, Exp. Date 03/31/2028. 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-0243-2026.