CareFusion 213, LLC BD ChloraPrep CLear, and 70% v/v isopropyl alcohol) recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep
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
The hazard: Sterility or particulate concern
Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
What the notice says: 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
Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.
Symptoms and when to call a doctor
Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- D-0651-2026
- Published
- July 8, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- CareFusion 213, LLC
- Product type
- Prescription & OTC drugs
- Units affected
- 18,000 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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.
Products covered by this recall
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
Check your product
The notice names 32 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 4088933
- Exp 03
- 31
- 2027
- 4177711
- 4195438
- Exp 06
- 30
- 5051114
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 03
- 31
- 2027
- 4177711
- 4195438
- Exp 06
- 30
- 02
- 29
- 2028
- 5070540
- Exp 03
- 5106
- 04
- 5141607
- Exp 05
- 5196
- 07
- 2028. — 18
- 000 units
NDC number
On the carton and again on the bottle or blister label.
- 54365-400-31
Model or item number
On the rating label, the box or the instruction sheet.
- 930480NSB — Lot
Package size
Match the net weight or the piece count on the front of the pack.
- 1 mL
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Sterility
CareFusion 213, LLC — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
- Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
- Report any infection or reaction you think the product caused to FDA MedWatch.
- Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
- Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: CareFusion 213, LLC — 1550 Northwestern Dr, El Paso, TX, 79912-8000
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was CareFusion 213, LLC prescription & otc drugs 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 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
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code 4088933, Exp 03, 31; best-by date 03 or 31; model number 930480NSB — Lot. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
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