CLASS I Drug recall · Reported 5 May 2021 · FDA Enforcement Report

ChloraPrep With Tint 2% w/v chlorhexidine gluconate recalled

CareFusion 213 is recalling ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol, distributed nationwide in the US. The recall was initiated on 19 Mar 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot and Exp Date: 0011737, 1/31/2023; 0020739, 1/31/2023; 0023790, 1/31/2023; 0037278, 1/31/2023; 0037279, 1/31/2023; 0038209, 1/31/2023; 0044734, 12/31/2022; 0007625, 10/31/2022; 0007630, 12/31/2022; 8095632, 3/31/2021; 8116723, 4/30/2021; 8127657, 4/30/2021; 8135651, 5/31/2021; 8137527, 5/31/2021; 8151741, 5/31/2021; 8158638, 5/31/2021; 8164530, 6/30/2021; 8178658, 6/30/2021; 8193779, 6/30/2021; 8197517, 6/30/2021; 8198765, 7/31/2021; 8212881, 7/31/2021; 8220737, 7/31/2021; 8226561, 7/31/2021; 8235991, 8/31/2021; 8249940, 8/31/2021; 8295569, 10/31/2021; 8304501, 10/31/2021; 8304849, 10/31/2021; 8306694, 10/31/2021; 8311791, 10/31/2021; 8334983, 11/30/2021; 8347719, 11/30/2021; 9008965, 12/31/2021; 9011841, 12/31/2021; 9031893, 1/31/2022; 9037824, 1/31/2022; 9038599, 1/31/2022; 9042938, 1/31/2022; 9044573, 1/31/2022; 9045831, 2/28/2022; 9051563, 2/28/2022; 9052565, 2/28/2022; 9053560, 2/28/2022; 9058847, 2/28/2022; 9059821, 2/28/2022; 9067665, 2/28/2022; 9072856, 2/28/2022; 9086532, 3/31/2022; 9087985, 3/31/2022; 9122538, 4/30/2022; 9126562, 4/30/2022; 9126564, 4/30/2022; 9137903, 5/31/2022; 9137904, 5/31/2022; 9154908, 5/31/2022; 9168975, 6/30/2022; 9171618, 6/30/2022; 9191256, 6/30/2022; 9218464, 7/31/2022; 9218595, 7/31/2022; 9221444, 7/31/2022; 9228305, 8/31/2022; 9241932, 8/31/2022; 9247742, 8/31/2022; 9249471, 8/31/2022; 9257903, 8/31/2022; 9263093, 9/30/2022; 9267133, 9/30/2022; 9269603, 9/30/2022; 9282881, 9/30/2022; 9284875, 9/30/2022; 9284881, 9/30/2022; 9289669, 9/30/2022; 9290455, 10/31/2022; 9291279, 10/31/2022; 9295914, 10/31/2022; 9296395, 10/31/2022; 9305775, 11/30/2022; 9311076, 2/28/2023; 9316348, 10/31/2022; 9317310, 11/30/2022; 9317312, 11/30/2022; 9324565, 11/30/2022; 9337530, 11/30/2022; 9341852, 11/30/2022; 9345911, 11/30/2022; 0098528, 12/31/2022;

Quantity recalled6,869,400 cartons

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-0346-2021
FDA event ID: 87592
Recalling firm: CareFusion 213, El Paso, TX
Classification: Class I
Status: Terminated
Recall initiated: 19 Mar 2021
FDA classified: 26 Apr 2021
Reported: 5 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility

Timeline

19 Mar 2021	Recall initiated by company
26 Apr 2021	Classified by FDA	+38 days
5 May 2021	Published 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

Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

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

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, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415

Where it was distributed

Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot and Exp Date: 0011737, 1/31/2023; 0020739, 1/31/2023; 0023790, 1/31/2023; 0037278, 1/31/2023; 0037279, 1/31/2023; 0038209, 1/31/2023; 0044734, 12/31/2022; 0007625, 10/31/2022; 0007630, 12/31/2022; 8095632, 3/31/2021; 8116723, 4/30/2021; 8127657, 4/30/2021; 8135651, 5/31/2021; 8137527, 5/31/2021; 8151741, 5/31/2021; 8158638, 5/31/2021; 8164530, 6/30/2021; 8178658, 6/30/2021; 8193779, 6/30/2021; 8197517, 6/30/2021; 8198765, 7/31/2021; 8212881, 7/31/2021; 8220737, 7/31/2021; 8226561, 7/31/2021; 8235991, 8/31/2021; 8249940, 8/31/2021; 8295569, 10/31/2021; 8304501, 10/31/2021; 8304849, 10/31/2021; 8306694, 10/31/2021; 8311791, 10/31/2021; 8334983, 11/30/2021; 8347719, 11/30/2021; 9008965, 12/31/2021; 9011841, 12/31/2021; 9031893, 1/31/2022; 9037824, 1/31/2022; 9038599, 1/31/2022; 9042938, 1/31/2022; 9044573, 1/31/2022; 9045831, 2/28/2022; 9051563, 2/28/2022; 9052565, 2/28/2022; 9053560, 2/28/2022; 9058847, 2/28/2022; 9059821, 2/28/2022; 9067665, 2/28/2022; 9072856, 2/28/2022; 9086532, 3/31/2022; 9087985, 3/31/2022; 9122538, 4/30/2022; 9126562, 4/30/2022; 9126564, 4/30/2022; 9137903, 5/31/2022; 9137904, 5/31/2022; 9154908, 5/31/2022; 9168975, 6/30/2022; 9171618, 6/30/2022; 9191256, 6/30/2022; 9218464, 7/31/2022; 9218595, 7/31/2022; 9221444, 7/31/2022; 9228305, 8/31/2022; 9241932, 8/31/2022; 9247742, 8/31/2022; 9249471, 8/31/2022; 9257903, 8/31/2022; 9263093, 9/30/2022; 9267133, 9/30/2022; 9269603, 9/30/2022; 9282881, 9/30/2022; 9284875, 9/30/2022; 9284881, 9/30/2022; 9289669, 9/30/2022; 9290455, 10/31/2022; 9291279, 10/31/2022; 9295914, 10/31/2022; 9296395, 10/31/2022; 9305775, 11/30/2022; 9311076, 2/28/2023; 9316348, 10/31/2022; 9317310, 11/30/2022; 9317312, 11/30/2022; 9324565, 11/30/2022; 9337530, 11/30/2022; 9341852, 11/30/2022; 9345911, 11/30/2022; 0098528, 12/31/2022;

Where was it sold?

Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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

7 other products · FDA event 87592

This product is part of a recall event; the main page for the event is ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) recalled.

Reported	Class	Recall	Company	Reason	Where
5 May 2021	CLASS I	ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) recalled	CareFusion 213	Sterility	Nationwide
5 May 2021	CLASS I	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
5 May 2021	CLASS II	ChloraPrep With Tint 2% w/v chlorhexidine gluconate recalled	CareFusion 213	Manufacturing (CGMP) Deviations	Nationwide
5 May 2021	CLASS I	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
5 May 2021	CLASS II	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
5 May 2021	CLASS II	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
5 May 2021	CLASS II	ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) recalled	CareFusion 213	Manufacturing (CGMP) Deviations	Nationwide

More recalls from CareFusion 213

All 48

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide