Class II
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
- Recall number
- D-0690-2026
- Report date
- July 22, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- CareFusion 213, LLC
- Generic names
- CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
- Brand names
- CHLORAPREP ONE-STEP
- Product NDCs
- 54365-400
Code and lot information
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, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, Exp. 5/31/2028; 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, Exp. 6/30/2028; 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, Exp. 7/31/2028; 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189, Exp. 8/31/2028; 5254509, 5274692, 5276968, 5279226, 5280240, Exp. 9/30/2028; 5305661, 5307185, 5309623, 5310701, Exp. 10/31/2028; 5346128, 5350797, Exp. 12/31/2028; 6031034, 6031234, 6037918, Exp. 1/31/2029; 6051588, 6054213, 6062168, 6063361, Exp. 2/28/2029; 6069891, Exp. 3/31/2029; 6111107, Exp. 4/30/2029.
Distribution
U.S.A. Nationwide
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.