ChloraPrep One-Step antiseptic 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 area, compromising sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source states this is an FDA Class II recall of a sterile pharmaceutical product where the manufacturing defect (wrinkled lidding breaching seal) raises risk of loss of sterility—a critical quality attribute for a topical antiseptic used in clinical settings. Although no illnesses or injuries are reported, the hazard is a direct risk of harm from compromised sterility of a product intended for patient care.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step, a topical antiseptic solution containing 2% chlorhexidine gluconate and 70% isopropyl alcohol, supplied in 1 mL applicators. The recall affects multiple lot numbers with expiration dates ranging from June 2026 through May 2027, distributed nationwide in the USA and other countries.
The product is being recalled due to wrinkles in the paper lidding which may breach the seal area. This manufacturing defect raises concerns about the loss of sterile assurance of the product.
Consumers and healthcare facilities that have received affected lots should stop using the product and contact CareFusion 213, LLC or their healthcare provider for further instructions regarding disposal or replacement. The affected lot numbers and expiration dates are detailed in the FDA's official recall notice.
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-defect
- 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 # 3201277
- Exp Date: 06/30/2026
- Lot # 3213912
- 3214206
- 3214914
- 3215710
- 3227485
- Exp Date: 07/31/2026
- Lot # 3234036
- 3234037
- 3236460
- 3237244
- 3243095
- 3263576
- 3263580
- 3264318
- Exp Date: 08/31/2026
- Lot # 3266655
- 3266657
- 3270586
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORAPREP ONE-STEP
- SevereChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
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 Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
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 Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08