ChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators nationwide because affected units may have open or incomplete seals on the packaging, which could compromise sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: This is an FDA Class II recall involving a sterile topical drug product with a packaging defect (open or incomplete seals) that could compromise sterility assurance. Class II recalls meet the "Severe" threshold per the rubric when they involve risk of significant harm, and loss of sterility assurance on a topical antiseptic used in medical settings presents that risk.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) in 60 × 1 mL sterile applicator cartons, 0.03 fl oz (1 mL) each, distributed nationwide. The affected product may exhibit an open or incomplete seal on the packaging of the applicator, which could compromise the product's sterility assurance.
The recall affects approximately 43,066,599 units identified by specific lot numbers and expiration dates ranging from February 2027 through April 2029. Affected lot numbers include 4062535, 4065201, 4066446, 4141090, 4180288, 4197695, 4197697, 4180291, 4219454, 4221945, 4221966, 4222853, 4224361, 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, 5124984, 5127231, 5129058, 5126398, 5129488, 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189, 5254509, 5274692, 5276968, 5279226, 5280240, 5305661, 5307185, 5309623, 5310701, 5346128, 5350797, 6031034, 6031234, 6037918, 6051588, 6054213, 6062168, 6063361, 6069891, and 6111107.
Consumers should check their ChloraPrep One-Step applicators for open or incomplete seals before use. If an open or incomplete seal is found, the product should not be used. Patients and healthcare providers with questions or to report adverse events should contact CareFusion 213, LLC or the FDA.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Affected units
- 43,066,599
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)
- Lots: 4062535
- 4065201
- 4066446
- Exp. 2/28/2027
- 4141090
- Exp. 5/31/2027
- 4180288
- 4197695
- 4197697
- 4180291
- Exp. 6/30/2027
- 4219454
- 4221945
- 4221966
- 4222853
- 4224361
- Exp. 7/31/2027
- 4228482
- 4248656
- 4249026
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 Applicators Recalled Due to Sterility Assurance Failure
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 Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
Same manufacturer · CareFusion 213, LLC
See all →- SeverePurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
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
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereArrow peritoneal lavage catheter kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24
- SevereArrow paracentesis kit JHH contains drugs from a recalled supplier
FDA (Devices) · 2026-06-24
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24
Similar recalls
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- 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
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Topical Solution Sterility Assurance Recall
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08