CareFusion Recalls Non-Sterile ChloraPrep Solution Due to Microbial Contamination Risk
CareFusion 213, LLC is recalling non-sterile ChloraPrep With Tint solution distributed in Puerto Rico and Oman due to potential fungal contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a severity score of at least 4 (Severe). The hazard involves potential fungal contamination leading to package breach in a non-sterile medical product.
Plain-English summary
CareFusion 213, LLC has initiated a Class I recall of ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution. The affected product is the Hi-Lite Orange variant, packaged as 0.10 fl. oz. (3 ml) applicators with 25 per carton. A total of 36 cartons are involved in this recall effort.
The recall addresses a potential microbial contamination issue. Specifically, there is a risk that Aspergillus penicillioides, a type of fungus, may grow on the product if it is stored at the labeled conditions of 30°C/75% Relative Humidity for more than six months. This fungal growth could result in a breach of the package integrity.
The recalled lots include but are not limited to Lot # 0038209 (Expiration Date: 01/31/2023) and Lot # 0098528 (Expiration Date: 02/28/2023). These products were distributed in Zone IV regions, specifically Puerto Rico and Oman. The recall was issued under FDA Drug Safety and Availability guidelines.
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, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Antiseptic Solution
- Affected units
- 36
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 (3)
- Exp. 01/31/2023
- 0098528
- Exp. 02/28/2023.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same manufacturer · CareFusion 213, LLC
See all →- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15