Class IIOngoing
BD ChloraPrep Hi-Lite Orange recall
FDA recall D-0648-2026 · initiated Jun 11, 2026
By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 8, 2026How we research
CareFusion 213, LLC recalled BD ChloraPrep Hi-Lite Orange in Jun 2026 — an FDA Class II recall (D-0648-2026) 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
Details
- Product
- BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, 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 with Tint →
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-0648-2026) 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-0648-2026 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?
- Distribution: Distributed Nationwide in the USA. The affected lot numbers and expiration dates are listed in the official FDA enforcement record for recall D-0648-2026, initiated Jun 2026.