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 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
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 .
- 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.