Quick answers
- What is Chloraprep?
- Chloraprep is a brand name of Chlorhexidine and isopropyl alcohol, an over-the-counter medicine. The FDA NDC Directory lists 3 Chloraprep products in 1 strength and form.
- Who makes Chloraprep?
- Becton Dickinson Co holds the FDA application for Chloraprep (NDA021555, approved October 7, 2002). 1 other company (repackagers or distributors) also list Chloraprep products.
- Is there a generic or store brand of Chloraprep?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Chloraprep product. Ask your pharmacist whether one is right for you.
- Has Chloraprep been recalled?
- FDA enforcement reports list 27 recalls of Chloraprep products; the newest started July 9, 2026. A recall usually concerns specific lots, not every product.
What Chloraprep is
Each Chloraprep product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Chlorhexidine and isopropyl alcohol · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| chlorhexidine gluconate 20 mg/mL · isopropyl alcohol 70% solution (topical) | ChloraPrep One-Step, Chloraprep, ChloraPrep Swabstick | 2 products, 1 company | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Chlorhexidine and isopropyl alcohol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021555 | Becton Dickinson Co | October 7, 2002 | 3 |
Companies that list Chloraprep
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Chloraprep products.
- CareFusion 213 LLC2 products
- HF Acquisition Co LLC, DBA HealthFirst1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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July 9, 2026 · Class II · Ongoing · D-0690-2026
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, D — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0643-2026
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
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 applic — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0645-2026
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
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400 — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0646-2026
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
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0647-2026
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
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catal — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0648-2026
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
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, b — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0651-2026
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
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365- — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0650-2026
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
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 54 — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0649-2026
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
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, — CareFusion 213, LLC
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June 11, 2026 · Class II · Ongoing · D-0652-2026
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
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 543 — CareFusion 213, LLC
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May 28, 2026 · Class II · Ongoing · D-0623-2026
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di — CareFusion 213, LLC
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May 28, 2026 · Class I · Ongoing · D-0624-2026
Non-Sterility: Due to presence of Aspergillus penicillioides.
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of B — CareFusion 213, LLC
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May 28, 2026 · Class I · Ongoing · D-0625-2026
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di — CareFusion 213, LLC
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May 28, 2026 · Class II · Ongoing · D-0622-2026
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson — CareFusion 213, LLC
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December 17, 2025 · Class II · Ongoing · D-0243-2026
Lack of Assurance of Sterlity
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 — CareFusion 213, LLC
Showing the newest 15 of 27.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.