The Recall Desk
SevereFDA (Drugs)·D-0690-2026·Announced 2026-07-22

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.

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 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
Hazard
  • sterility-assurance
  • packaging-seal-defect

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

Same category