Agency classClass IOur severity:Severe FDA (Drugs)·D-0346-2021·Announced 2021-05-05

CareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination

CareFusion is recalling ChloraPrep antiseptic applicators because fungal growth breached package integrity. The product is non-sterile, but the breach compromises the sterility of the applicators.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum severity score of 4 (Severe).

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep With Tint 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol Non-Sterile Solution. The recall involves 6,869,400 cartons of the product, which contains 25 applicators per carton. The product was distributed nationwide in the USA and to several international locations, including Singapore, Chile, Oman, and Brazil.

The recall was initiated because, at labeled storage conditions of 30°C and 75% relative humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. While the solution itself is labeled as non-sterile, the applicators are sterile if the package is intact. The breach of package integrity compromises the sterility of the applicators.

Healthcare facilities and consumers should stop using the affected lots and return them to the distributor or manufacturer for credit. The affected lots have expiration dates ranging from March 2021 to February 2023.

The recalled product

Product: 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…
Manufacturer: CareFusion 213, LLC
Category: Medical Device — Antiseptic Applicators
Hazard: microbial-contamination
package-integrity-breach
Affected units: 6,869,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot and Exp Date: 0011737
1/31/2023
0020739
0023790
0037278
0037279
0038209
0044734
12/31/2022
0007625
10/31/2022
0007630
8095632
3/31/2021
8116723
4/30/2021
8127657
8135651
5/31/2021
8137527

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by CareFusion 213, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · CareFusion 213, LLC

See all →

Severe
ChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
Severe
PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
Severe
ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
FDA (Drugs) · 2026-07-08
Severe
ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
Severe
ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08

Same hazard · microbial contamination