CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange, and 70% v/v isopropyl Recall 2026
CHLORAPREP ONE-STEPIssued June 11, 2026Updated Reviewed by the Recall Watch editorial team
CHLORAPREP ONE-STEP 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 applicat — recalled per FDA on 6/11/2026. Reason: 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
- Issued
- Jun 11, 2026
- Brand
- CHLORAPREP ONE-STEP
- Distribution
- 1 states
- Lots affected
- 20
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
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What's recalled
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.
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Why it was recalled
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
Affected products & lot numbers20 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| 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 |
Where was it sold1 state
Distributed Nationwide in the USA
More recalls like this8 related — by brand, contaminant, and category
Other CHLORAPREP ONE-STEP recalls
Recent Medications recalls
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- Par Pharmaceutical Par Health Issues Voluntary Nationwide Two Lots Recall 20262026
Frequently asked questions
Is the CHLORAPREP ONE-STEP recall still active?
Yes, this recall is currently active as of June 11, 2026. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: 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. Check the label on your product.
What should I do if I have the recalled CHLORAPREP ONE-STEP?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.