CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalled

CareFusion 213 is recalling BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl, distributed nationwide in the US. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.
NDC54365-400
Quantity recalled125 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0650-2026
FDA event ID
99217
Recalling firm
CareFusion 213, El Paso, TX
Manufacturer
CareFusion 213, LLC
Classification
Class II
Status
Ongoing
Recall initiated
11 Jun 2026
FDA classified
29 Jun 2026
Reported
8 Jul 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

11 Jun 2026Recall initiated by company
29 Jun 2026Classified by FDA+18 days
8 Jul 2026Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Where it was distributed

Distributed Nationwide in the USA

Nationwide

Questions about this recall

Why was it 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

Which lots are affected?

Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.

Where was it sold?

Distributed Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 99217

This product is part of a recall event; the main page for the event is BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213.

More recalls from CareFusion 213

All 48
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-stepCareFusion 213SterilityNationwide

Other Chlorhexidine Gluconate recalls

All 35
ReportedClassRecallCompanyReasonWhere
DrugCLASS II2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine GluconateSage ProductsOtherNationwide
DrugCLASS IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-stepCareFusion 213SterilityNationwide
DrugCLASS IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-stepCareFusion 213SterilityNationwide