BD ChloraPrep Hi-Lite Orange recall
FDA recall D-0643-2026 · initiated Jun 11, 2026
CareFusion 213, LLC recalled BD ChloraPrep Hi-Lite Orange in Jun 2026 — an FDA Class II recall (D-0643-2026) because Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
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: 1,800 units
Details
- Product
- BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
- Recalling company
- CareFusion 213, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Jun 11, 2026
- FDA report date
- Jul 8, 2026
This recall is linked to a product we cover: Chloraprep One-Step →
Frequently asked
- Was BD ChloraPrep Hi-Lite Orange recalled?
- CareFusion 213, LLC recalled BD ChloraPrep Hi-Lite Orange in Jun 2026 — an FDA Class II recall (D-0643-2026) because Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was BD ChloraPrep Hi-Lite Orange recalled?
- Per the FDA enforcement record, the reason for recall D-0643-2026 was: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- Is a recalled BD ChloraPrep Hi-Lite Orange 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 Hi-Lite Orange are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.. 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-0643-2026.