BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- Agency
- FDA Drug
- Recall date
- Jun 11, 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) 100 x 10
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
Quantity: 100 units
Code or lot text: Lot: 4190081, Exp 06/30/2027
- LOT
- Exp 06/30/2027
- LOT
- Lot: 4190081
- NDC
- 54365-400
- NDC
- 54365-400-34
- RECALL-NUMBER
- D-0652-2026
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiar
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB
Quantity: 18,000 units
Code or lot text: Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028.
- LOT
- 4177711
- LOT
- 4195438
- LOT
- 5051114
- LOT
- 5070540
- LOT
- 5106254
- LOT
- 5141607
- LOT
- 5196494
- LOT
- Exp 02/29/2028
- LOT
- Exp 03/31/2027
- LOT
- Exp 03/31/2028
- LOT
- Exp 04/30/2028
- LOT
- Exp 05/31/2028
- LOT
- Exp 06/30/2027
- LOT
- Exp 07/31/2028.
- LOT
- Lot: 4088933
- NDC
- 54365-400
- NDC
- 54365-400-31
- RECALL-NUMBER
- D-0651-2026
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Quantity: 146,600 units
Code or lot text: Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 5338383, Exp.11/30/2028, 5343740, 6008264, Exp. 12/31/2028, 6009889, 6031246, 6033968, Exp. 1/31/2029, 6041203, 6059301, 6061876, Exp. 2/28/2029, (b) 3293904, Exp. 10/31/2026, 3333265, Exp. 11/30/2026, 4031672, 1/31/2027, 4061583, 4068589, Exp. 2/28/2027, 4081770, Exp. 3/31/2027, 4154588, 4166005, Exp. 5/31/2027, 4213945, 4215736, Exp. 7/31/2027, 4241055, Exp. 8/31/2027, 4262802, 4270628, Exp. 9/30/2027, 4309640, Exp. 10/31/2027, 5114931, Exp. 4/30/2028, 5135055, 5136752, 5143453, Exp. 5/31/2028, 5165652, Exp. 6/30/2028.
- LOT
- (b) 3293904
- LOT
- 1/31/2027
- LOT
- 3199359
- LOT
- 3200136
- LOT
- 3212372
- LOT
- 3237018
- LOT
- 3243267
- LOT
- 3264290
- LOT
- 3313291
- LOT
- 3333265
- LOT
- 3334121
- LOT
- 4030693
- LOT
- 4031672
- LOT
- 4033380
- LOT
- 4058103
- LOT
- 4061583
- LOT
- 4065931
- LOT
- 4068589
- LOT
- 4081770
- LOT
- 4093245
- LOT
- 4094302
- LOT
- 4145548
- LOT
- 4146564
- LOT
- 4154588
- LOT
- 4166005
- LOT
- 4191049
- LOT
- 4213945
- LOT
- 4214794
- LOT
- 4215736
- LOT
- 4218807
- LOT
- 4241055
- LOT
- 4249036
- LOT
- 4254217
- LOT
- 4262802
- LOT
- 4270628
- LOT
- 4275877
- LOT
- 4276225
- LOT
- 4276231
- LOT
- 4277387
- LOT
- 4304554
- LOT
- 4304577
- LOT
- 4305852
- LOT
- 4309640
- LOT
- 4330005
- LOT
- 4332555
- LOT
- 4348701
- LOT
- 4366429
- LOT
- 5016607
- LOT
- 5016609
- LOT
- 5017377
- LOT
- 5018775
- LOT
- 5050107
- LOT
- 5050801
- LOT
- 5076869
- LOT
- 5077722
- LOT
- 5079413
- LOT
- 5106576
- LOT
- 5111556
- LOT
- 5112405
- LOT
- 5114931
- LOT
- 5118607
- LOT
- 5119243
- LOT
- 5119244
- LOT
- 5127658
- LOT
- 5135055
- LOT
- 5136752
- LOT
- 5139589
- LOT
- 5143453
- LOT
- 5154809
- LOT
- 5157377
- LOT
- 5160633
- LOT
- 5160695
- LOT
- 5165652
- LOT
- 5177477
- LOT
- 5195773
- LOT
- 5195785
- LOT
- 5210771
- LOT
- 5210773
- LOT
- 5210784
- LOT
- 5219294
- LOT
- 5233581
- LOT
- 5247554
- LOT
- 5247987
- LOT
- 5310578
- LOT
- 5338383
- LOT
- 5343740
- LOT
- 6008264
- LOT
- 6009889
- LOT
- 6031246
- LOT
- 6033968
- LOT
- 6041203
- LOT
- 6059301
- LOT
- 6061876
- LOT
- Exp 1/31/2027
- LOT
- Exp 6/30/2026
- LOT
- Exp 6/30/2027
- LOT
- Exp. 1/31/2028
- LOT
- Exp. 1/31/2029
- LOT
- Exp. 10/31/2026
- LOT
- Exp. 10/31/2027
- LOT
- Exp. 11/30/2026
- LOT
- Exp. 11/30/2027
- LOT
- Exp. 12/31/2027
- LOT
- Exp. 12/31/2028
- LOT
- Exp. 2/28/2027
- LOT
- Exp. 2/28/2029
- LOT
- Exp. 2/29/2028
- LOT
- Exp. 3/31/2027
- LOT
- Exp. 3/31/2028
- LOT
- Exp. 4/30/2028
- LOT
- Exp. 5/31/2027
- LOT
- Exp. 5/31/2028
- LOT
- Exp. 6/30/2028.
- LOT
- Exp. 7/31/2026
- LOT
- Exp. 7/31/2027
- LOT
- Exp. 7/31/2028
- LOT
- Exp. 8/31/2026
- LOT
- Exp. 8/31/2027
- LOT
- Exp. 8/31/2028
- LOT
- Exp. 9/30/2027
- LOT
- Exp.10/31/2028
- LOT
- Exp.11/30/2028
- LOT
- Lot: (a) 3214024
- NDC
- 54365-400
- NDC
- 54365-400-32
- RECALL-NUMBER
- D-0645-2026
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Quantity: 1,800 units
Code or lot text: Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
- LOT
- 4066870
- LOT
- 4104107
- LOT
- 4233300 expires: 08/31/2027.
- LOT
- 4276125
- LOT
- Lot: a) 3362296
- LOT
- b) 4080695
- LOT
- expires: 02/28/2027
- LOT
- expires: 03/31/2027
- LOT
- expires: 09/30/2027
- LOT
- expires: 12/31/2026
- NDC
- 54365-400
- NDC
- 54365-400-35
- RECALL-NUMBER
- D-0643-2026
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Quantity: 7,650 units
Code or lot text: Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227747, 4250845, Exp 08/31/2027, 50872610, 5093809, Exp 03/31/2028, 5121323, Exp 04/30/2028. b) 3331331, Exp 11/30/2026, 4284935, Exp 10/31/2027, 4344682, Exp 11/30/2027, 5015852, Exp 01/31/2028, 5086227, Exp 03/31/2028.
- LOT
- 3217036
- LOT
- 3279434
- LOT
- 3286268
- LOT
- 3304460
- LOT
- 3346277
- LOT
- 4031686
- LOT
- 4039656
- LOT
- 4048949
- LOT
- 4060437
- LOT
- 4067207
- LOT
- 4092773
- LOT
- 4094978
- LOT
- 4106623
- LOT
- 4120371
- LOT
- 4129596
- LOT
- 4144918
- LOT
- 4193623 4200771
- LOT
- 4227747
- LOT
- 4250845
- LOT
- 4284935
- LOT
- 4344682
- LOT
- 5015852
- LOT
- 5086227
- LOT
- 50872610
- LOT
- 5093809
- LOT
- 5121323
- LOT
- Exp 01/31/2027
- LOT
- Exp 01/31/2028
- LOT
- Exp 02/28/2027
- LOT
- Exp 03/31/2027
- LOT
- Exp 03/31/2028.
- LOT
- Exp 04/30/2027
- LOT
- Exp 04/30/2028. b) 3331331
- LOT
- Exp 05/31/2027
- LOT
- Exp 06/30/2027
- LOT
- Exp 07/31/2026
- LOT
- Exp 08/31/2027
- LOT
- Exp 09/30/2026
- LOT
- Exp 10/31/2026
- LOT
- Exp 10/31/2027
- LOT
- Exp 11/30/2026
- LOT
- Exp 11/30/2027
- LOT
- Exp. 06/30/2026
- LOT
- Lot: a) 3194046
- NDC
- 54365-400
- NDC
- 54365-400-33
- RECALL-NUMBER
- D-0647-2026
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Quantity: 400 units
Code or lot text: Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.
- LOT
- 4034080
- LOT
- 4036599
- LOT
- 4081350
- LOT
- 4151258
- LOT
- 5008234
- LOT
- Exp 01/31/2027
- LOT
- Exp 03/31/2027
- LOT
- Exp 03/31/2028.
- LOT
- Exp 05/31/2027. 5084224
- LOT
- Exp 10/31/2026
- LOT
- Exp 11/30/2025
- LOT
- Exp 12/31/2027. b) 2320053
- LOT
- Lot: a) 3291614
- NDC
- 54365-400
- NDC
- 54365-400-38
- RECALL-NUMBER
- D-0648-2026
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Quantity: 1,200 units
Code or lot text: Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028
- LOT
- 3345111
- LOT
- 4037991
- LOT
- 4114505
- LOT
- 4156664
- LOT
- 4270441
- LOT
- 5016842
- LOT
- 5078395
- LOT
- 5112542
- LOT
- Exp 01/31/2027
- LOT
- Exp 03/31/2028
- LOT
- Exp 04/30/2027
- LOT
- Exp 04/30/2028 b) 3330777
- LOT
- Exp 05/31/2027
- LOT
- Exp 09/30/2027
- LOT
- Exp 10/31/2026
- LOT
- Exp 12/31/2026
- LOT
- Exp 12/31/2027
- LOT
- Lot: a) 4157798
- NDC
- 54365-400
- NDC
- 54365-400-36
- RECALL-NUMBER
- D-0649-2026
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Quantity: 125 units
Code or lot text: Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.
- LOT
- 5069651
- LOT
- Exp 01/31/2028
- LOT
- Exp 03/31/2028.
- LOT
- Exp 12/31/2026 b) 5028798
- LOT
- Lot: a) 3352149
- NDC
- 54365-400
- NDC
- 54365-400-39
- RECALL-NUMBER
- D-0650-2026
BD PurPrep, (Povidone-iodine 8
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
Quantity: N/A
Code or lot text: Lot: 4298581, expires: 09/30/2026.
- LOT
- Lot: 4298581
- LOT
- expires: 09/30/2026.
- NDC
- 54365-014
- NDC
- 54365-014-41
- NDC
- 54365-014-42
- RECALL-NUMBER
- D-0644-2026
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
Quantity: 10,500 units
Code or lot text: Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
- LOT
- 3319524
- LOT
- 3324094
- LOT
- 3343541
- LOT
- 3357638
- LOT
- 4010202
- LOT
- 4206771
- LOT
- 4267824
- LOT
- 4270191
- LOT
- 4282285
- LOT
- 4338352
- LOT
- 5053657
- LOT
- 5121340
- LOT
- Exp. 11/30/2026
- LOT
- Exp. 11/30/2027
- LOT
- Exp. 12/31/2026
- LOT
- Exp. 2/29/2028
- LOT
- Exp. 4/30/2028.
- LOT
- Exp. 7/31/2027
- LOT
- Exp. 9/30/2026
- LOT
- Exp.9/30/2027
- LOT
- Lot: 3279063
- NDC
- 54365-400
- NDC
- 54365-400-30
- RECALL-NUMBER
- D-0646-2026
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: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
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 .
- updated
- 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.