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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 (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) — 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
11
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified summary of the official U.S. Food and Drug Administration notice · Issued June 11, 2026 · Last synced Nov 1, 2026

What's recalled

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.

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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 numbers
11 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
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.
Where was it sold
1 state

Distributed Nationwide in the USA

nationwide
Official noticefda.gov
More recalls like this
8 related — by brand, contaminant, and category

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) 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.. 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.