ChloraPrep One-Step Topical Solution Sterility Assurance Recall
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal, compromising sterility assurance.
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: This is an FDA Class II recall involving a sterile topical antiseptic product where loss of sterility assurance could result in contamination and infection risk if used in clinical settings. The compromise of sterile packaging of a topical preparation used on skin and surgical sites presents significant potential for harm.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) 1.5 mL applicators due to lack of assurance of sterility. The recall is caused by wrinkles in the paper lidding that may breach the seal area.
The affected product is BD ChloraPrep FREPP Clear 1.5 mL applicators (NDC 54365-400-30), 20 applicators per unit. Multiple lot numbers with expiration dates ranging from May 31, 2026 through October 31, 2027 are included in this recall. The product has been distributed nationwide in the USA and to other foreign locations.
Consumers or healthcare providers who have this product should stop using it and contact their healthcare provider if they have any concerns. The product should not be used due to the potential loss of sterility.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- sterility-loss
- seal-breach
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 # 3143780
- 3151595
- 3152898
- 3152906
- 3157235
- 3158139
- 3159803
- 3166919
- 3167620
- 3191056
- Exp Date: 05/31/2026
- Lot # 3171115
- 3172853
- 3177820
- 3193968
- 3194750
- 3199123
- 3201195
- 3206618
- 3212202
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORAPREP ONE-STEP
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAccucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08
- ModerateMedline Ophthalmic Pack with Lidocaine Injection Kits Recalled
FDA (Devices) · 2026-07-08