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Stop using now Drug recall · FDA · Published June 23, 2020

CareFusion ChloraPrep With Tint 3mL Applicators Recall: Non-Sterility Risk

CareFusion recalls 25-pack of ChloraPrep With Tint 3mL applicators due to Aspergillus Penicilloides contamination. Stop using if you have these items.

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

🇺🇸 FDA recall #D-1510-2020DrugCareFusion ›
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Contact the company

Recalling firmCareFusion 213, LLC1550 Northwestern Dr · El Paso, TX 79912-8000
✎ GovInfoNow plain-language explainer

CareFusion is recalling 25-pack ChloraPrep With Tint 3mL applicators because they contain Aspergillus Penicilloides, a type of mold that can cause infections. This is a serious health risk for people using the product for medical purposes. Read more at govinfonow.com/recall/37000-carefusion-chloraprep-with-tint-3ml-applicators-recall-non-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37000-carefusion-chloraprep-with-tint-3ml-applicators-recall-non-sterility-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1510-2020

Cite this page

“CareFusion ChloraPrep With Tint 3mL Applicators Recall: Non-Sterility Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37000-carefusion-chloraprep-with-tint-3ml-applicators-recall-non-sterility-risk. Based on FDA recall #D-1510-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1510-2020%22&limit=1).

The FDA announced on June 23, 2020, that CareFusion 213, LLC is recalling ChloraPrep With Tint 3 mL applicators due to non-sterility. The product contains Aspergillus Penicilloides. Owners should contact the company for a refund.

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)) 3 mL applicators - Hi-Lite Orange
  • NDC: 054365-400-11
  • Lot codes: 7194739, 7214841, 7213558, 7227839, 7276589, 7198824, 7275718, 7289776, 7306916, 8011665, 8015801, 8031857, 8033645, 8127657, 8137527, 8157141, 8158638, 8164530, 8220737, 8235991, 8043978, 8306694, 8334983, 9031893, 9038599, 9042938, 9051563, 9053560, 9072856, 9086532, 9137904, 9087985, 9191256, 9168975, 9218464, 9218595, 9228305, 9241932, 9247742, 9249471, 9269603, 9296395, 9295914, 9311076, 9316348, 9324565, 9345911, 9305775, 0011737, 0023790, 0037279
  • Units affected: 2,800,800 applicators

The hazard

The product is being recalled due to the presence of Aspergillus Penicilloides. The FDA classified this as a Class I recall.

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 Scrub Teal Recall (2026-06-11), and BD ChloraPrep Clear 1mL Applicator Recall (2026-05-28). Other recent recalls of similar products include Carolina Infusion Recalls Quad-Mix Injectable (2026-09-10), TRP Gentle Eyes Lubricant Eye Drops Recall (2026-08-20), and Cipla Lanreotide Injection Recall (2026-03-13).

How to tell if you have this one

Check for the Hi-Lite Orange 25-applicator carton with CareFusion El Paso, TX label. Look for specific lot numbers and expiration dates listed in the recall notice.

  • Brand
    CareFusion
  • Category
    Drug
FDA recall event · 3 products

All 3 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
    Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Recall numberProduct, codes & lotsQuantityNDC
D-1509-2020BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32; Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/202312,500 applicators54365-400-32
D-1510-2020ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11; Lot #: 7194739, Exp. 06/25/2020; 7214841, Exp. Date 07/17/2020; 7213558, Exp. Date 07/16/2020; 7227839, Exp. Date 07/30/2020; 7276589, Exp. Date 09/20/2020; 7198824, Exp. Date 06/29/2020; 7275718, Exp. Date 09/19/2020; 7289776, Exp. Date 09/30/2020; 7306916, Exp. Date 10/12/2020; 8011665, Exp. Date 12/14/2020; 8015801, Exp. Date 12/18/2020; 8031857, Exp. Date 01/31/2021; 8033645, Exp. Date 01/31/2021; 8127657, Exp. Date 04/30/2021; 8137527, 8157141, 8158638, Exp. Date 05/31/2021; 8164530, Exp. Date 06/30/2021; 8220737, Exp. Date 07/31/2021; 8235991, Exp. Date 08/31/2021; 8043978, Exp. Date 01/31/2021; 8306694, Exp. Date 10/31/2021; 8334983, Exp. Date 11/30/2021; 9031893, 9038599, 9042938, Exp. Date 01/31/2022; 9051563, 9053560, 9072856, Exp. Date 02/28/2022; 9086532, Exp. Date 03/31/2022; 9137904, Exp. Date 05/31/2022; 9087985, Exp. Date 03/31/2022; 9191256, 9168975, Exp. Date 06/30/2022; 9218464, 9218595, Exp. Date 07/31/2022; 9228305, 9241932, 9247742, 9249471, Exp. Date 08/31/2022; 9269603, Exp. Date 09/30/2022; 9296395, 9295914, 9311076, Exp. Date 10/31/2022; 9316348, 9324565, 9345911, Exp. Date 11/30/2022; 9305775, Exp. Date 10/31/2022; 0011737, Exp. Date 12/31/2022; 0023790, 0037279, Exp. Date 01/31/2023.2,800,800 applicators—
D-1511-2020ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01; Lot #: 7240735, Exp. Date 08/09/2020; 7235540, Exp. Date. 08/06/2020; 7297579, Exp. Date 10/08/2020; 8003727, Exp. Date 11/29/2020; 8011688, 8012808, Exp.. Date 12/18/2020; 8095620, 8087784, 8095620, Exp. Date 03/31/2021; 8106737, 8130509, Exp. Date 04/30/2021; 8165721, 8187644, Exp. Date 06/30/2021; 8205560, Exp. Date 07/31/2021; 8247508, Exp. Date 08/31/2021; 8289654, Exp. Date 09/30/2021; 8155991, Exp. Date 05/31/2021; 8304783, Exp. Date 10/31/2021; 8337646, 8332585, 8338794, Exp. Date 11/30/2021; 9007921, 9015917, 9015920, Exp. date 12/31/2021; 9030934, 9045819, Exp. Date 01/31/2022; 9052554, 9059817, 9046572, 9071761, Exp. Date 02/28/2022; 9087982, 9087980, 9100768, 9101529, 9092575, 9105675, Exp. Date 03/31/2022; 9113528, 9123753, 9133928, Exp. Date 04/30/2022; 9135816, 9165856, Exp. Date 05/31/2022; 9199815, 9166196, 9198900, 9199815, 9194257, 9200420, Exp. Date 06/30/2022; 9205441, Exp. Date 07/31/2022; 9233323, 9233645, 9241929, 9238871, 9253785, Exp. Date 08/31/2022; 9261886, 9278673, 9266348, 9289666, Exp. Date 09/30/2022; 9293445, 9291336, 9297772, 9311057, 9305777, Exp. Date 10/31/2022; 9326162, 9344775, 9345956, Exp. Date 11/30/2022; 9352330, 0008777, 0016325, Exp. Date 12/31/2022; 0021072, 0030959, Exp. Date 01/31/2023, 0104864, Exp. Date 03/31/2023.4,272,300 applicators—
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately stop using the recalled ChloraPrep With Tint applicators as they contain mold that can cause infections.

Where it went and when

Where it was distributed

Distributed in Puerto Rico, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFLPuerto Rico: yesPR

FDA distribution: “Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,” 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 2.3 years after the firm started it.

1. Firm started the recall: Jun 23, 202012. FDA classified it Class I: Aug 19, 202023. Published in FDA’s Enforcement Report: Aug 26, 202034. FDA terminated the recall: Sep 28, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

Similar recalls

Recall: BD ChloraPrep Applicators Sterility Risk
BD ChloraPrepBD ChloraPrep Clear 1mL Applicators Recall: Contamination Risk from Aspergillus
BDCareFusion BD ChloraPrep Triple Swabsticks Recall: Risk of Contaminated Swabs
CareFusionAmerican Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, Inc

Other CareFusion recalls

CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL
July 9, 2026CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60
May 28, 2026CareFusion 213, LLC recalls BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36
April 22, 2026

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Keep exploring

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-1510-2020 (June 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1510-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA