Use caution Drug recall · FDA · Published July 7, 2020

CareFusion ChloraPrep With Tint Recall: Microbial Contamination Risk

CareFusion recalls ChloraPrep With Tint 2% chlorhexidine solution for potential fungal growth in humid climates. Affected lots sold in Zone IV regions with specific expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0266-2021Drug CareFusion ›

Use caution until it’s fixed

Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Take action

Contact the company

Recalling firmCareFusion 213, LLC1550 Northwestern Dr · El Paso, TX 79912-8000

✎ GovInfoNow plain-language explainer

CareFusion is recalling ChloraPrep With Tint 2% chlorhexidine solution due to potential fungal growth in humid climates. This could breach the product packaging and cause contamination if stored for over six months at 30°C/75% humidity. Read more at govinfonow.com/recall/36949-carefusion-chloraprep-with-tint-recall-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36949-carefusion-chloraprep-with-tint-recall-microbial-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0266-2021

Cite this page

“CareFusion ChloraPrep With Tint Recall: Microbial Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36949-carefusion-chloraprep-with-tint-recall-microbial-contamination-risk. Based on FDA recall #D-0266-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0266-2021%22&limit=1).

CareFusion 213, LLC voluntarily recalled ChloraPrep With Tint Non-Sterile Solution on July 7, 2020, according to the FDA. The product faces a Class I hazard due to potential microbial contamination from fungal growth in Zone IV regions.

How to tell if you have it

Brand: CareFusion
Product: ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange
Size: 0.10 fl. oz. (3 ml)
Packaging: 25 applicators in carton
NDC: 054365-400-11
Cat. No.: 260415
Lots: 0038209 (Exp. 01/31/2023), 0098528 (Exp. 02/28/2023)
Distribution: Puerto Rico and Oman

The hazard

The recall addresses the potential for growth of Aspergillus penicillioides, a type of fungus, in non-sterile products stored at labeled conditions of 30*C/75% Relative Humidity for more than 6 months. This fungal growth can result in a breach of package integrity.

Context

GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since 2011-11-08. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (2026-07-09), BD ChloraPrep Applicators (2026-06-11), and BD ChloraPrep Clear 1mL Applicator (2026-05-28). Other recent recalls of similar products include American Regent ACETYLCYSTEINE Solution (2026-07-24), Zep Alcohol Sanitizer Spray (2026-05-22), and Sunny Pharmtech Cyclophosphamide Injection (2026-07-17).

How to tell if you have this one

Check for the CareFusion El Paso, TX 79912 label and NDC 054365-400-11. Affected lots include 0038209 (exp. 01/31/2023) and 0098528 (exp. 02/28/2023) sold in climate zone IV regions.

Brand
CareFusion
Category
Drug

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
Distributed in Puerto Rico and Oman

Recall number	Product, codes & lots	Quantity	NDC
D-0265-2021	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400; All lots including but not limited to the following lots distributed in Zone IV: Lot # 0161217 Exp. 05/31/2023; 0211068 Exp. 07/31/2023; 0176660 Exp. 06/30/2023; 0188805 Exp. 06/30/2023; 0175874 Exp. 06/30/2023; 0151977 Exp. 05/31/2023; 0149328 Exp. 04/30/2023; 0085419 Exp. 03/31/2023	988 cartons	54365-400-32
D-0266-2021	ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415; All lots including but not limited to the following lots distributed in Zone IV: Lot # 0038209, Exp. 01/31/2023; 0098528, Exp. 02/28/2023.	36 cartons	—
D-0267-2021	ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400; All lots including but not limited to the following lot distributed in Zone IV: Lot # 0192894, Exp. 06/30/2023; 9080812 Exp 03/31/2022	280 cartons	—
D-0268-2021	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415; All lots including but not limited to the following lots distributed in Zone IV: Lot # 0107872, Exp. 04/30/2023; 0108556, Exp. 04/30/2023; 0148278, Exp. 04/30/2023; 0151978, Exp. 05/31/2023; 0155534, Exp. 05/31/2023; 0157085, Exp. 05/31/2023; 0160618, Exp. 05/31/2023; 0167907, Exp. 05/31/2023.	400 cartons	54365-400-33

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the NDC 054365-400-11 and affected lot numbers (0038209 or 0098528) on the packaging.

Where it went and when

Where it was distributed

Distributed in Puerto Rico.

FDA distribution: “Distributed in Puerto Rico and Oman” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Puerto Rico.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Jul 7, 2020Firm started the recall
Feb 19, 2021FDA classified it Class I
Mar 3, 2021Published in FDA’s Enforcement Report
Sep 29, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other CareFusion recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36949-carefusion-chloraprep-with-tint-recall-microbial-contamination-risk">CareFusion ChloraPrep With Tint Recall: Microbial Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0266-2021 (July 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0266-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.