Elevated site urgencyFDA Class II

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

Agency
FDA Drug
Recall date
Jul 9, 2026
Status
Ongoing
Company
CareFusion 213, LLC

1. What product was recalled?

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0

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

Quantity: 43,066,599 units

Code or lot text: 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.

LOT
4065201
LOT
4066446
LOT
4141090
LOT
4180288
LOT
4180291
LOT
4197695
LOT
4197697
LOT
4219454
LOT
4221945
LOT
4221966
LOT
4222853
LOT
4224361
LOT
4228482
LOT
4248656
LOT
4248961
LOT
4249026
LOT
4249818
LOT
4250729
LOT
5124984
LOT
5126398
LOT
5127231
LOT
5129058
LOT
5129488
LOT
5130576
LOT
5142947
LOT
5147432
LOT
5150160
LOT
5154671
LOT
5154673
LOT
5155824
LOT
5156442
LOT
5157968
LOT
5158031
LOT
5176326
LOT
5181074
LOT
5181676
LOT
5182660
LOT
5188102
LOT
5188103
LOT
5195818
LOT
5199118
LOT
5209474
LOT
5210853
LOT
5211212
LOT
5211907
LOT
5211985
LOT
5226576
LOT
5227151
LOT
5230531
LOT
5241733
LOT
5242057
LOT
5243430
LOT
5246952
LOT
5248189
LOT
5248375
LOT
5254509
LOT
5274692
LOT
5276968
LOT
5279226
LOT
5280240
LOT
5305661
LOT
5307185
LOT
5309623
LOT
5310701
LOT
5346128
LOT
5350797
LOT
6031034
LOT
6031234
LOT
6037918
LOT
6051588
LOT
6054213
LOT
6062168
LOT
6063361
LOT
6069891
LOT
6111107
LOT
Exp. 1/31/2029
LOT
Exp. 10/31/2028
LOT
Exp. 12/31/2028
LOT
Exp. 2/28/2027
LOT
Exp. 2/28/2029
LOT
Exp. 3/31/2029
LOT
Exp. 4/30/2028
LOT
Exp. 4/30/2029.
LOT
Exp. 5/31/2027
LOT
Exp. 5/31/2028
LOT
Exp. 6/30/2027
LOT
Exp. 6/30/2028
LOT
Exp. 7/31/2027
LOT
Exp. 7/31/2028
LOT
Exp. 8/31/2027
LOT
Exp. 8/31/2028
LOT
Exp. 9/30/2028
LOT
Lots: 4062535
NDC
54365-400
NDC
54365-400-31
RECALL-NUMBER
D-0690-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. unchanged
  2. created

10. Where is the official source?

Open the official FDA Drug source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.