Lower riskDrug recall · FDA · Published August 25, 2023
BD ChloraPrep Clear Sterile Solution Recall: Risk of Mold Growth After 12 Months
BD ChloraPrep Clear 2% chlorhexidine and 70% isopropyl alcohol solution may grow mold after 12 months if stored at 30°C/75% humidity. Recalled lots expire at 9/30/2025 but stability data shows risk of Aspergillus penicillioides growth beyond 12 months.
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
Take action
Contact the company
📍Recalling firmCareFusion 213, LLC1550 Northwestern Dr · El Paso, TX 79912-8000
“BD ChloraPrep Clear Sterile Solution Recall: Risk of Mold Growth After 12 Months.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33162-bd-chloraprep-clear-sterile-solution-recall-risk-of-mold-growth. Based on FDA recall #D-1168-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1168-2023%22&limit=1).
The FDA announced on August 25, 2023, that CareFusion 213, LLC is recalling BD ChloraPrep Clear sterile solution due to stability data not supporting the labeled 36-month expiry. The product may exhibit growth of Aspergillus penicillioides if stored beyond 12 months.
Stability data does not support the labeled 36-month expiry for impacted lots of BD ChloraPrep Clear 1 mL Applicator. Stability studies indicate that if stored at 30°C/75% relative humidity continuously beyond 12 months, the product may exhibit growth of Aspergillus penicillioides.
Context
GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since 2011-11-08. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (2026-07-09), CareFusion ChloraPrep FREPP 500x1.5mL (2026-06-11), and CareFusion BD ChloraPrep FREPP Clear 1.5mL Applicator (2026-05-28). Other recent recalls of similar products include ClearLife Allergy Nasal Spray (2025-12-12), Blaine Labs Fungal Fusion Antifungal Solution (2026-04-08), and Baxter Sterile Water for Irrigation (2025-12-22).
How to tell if you have this one
Check for lot numbers 2272350 or 2301939 with expiration date 09/30/2025 on the packaging. The product comes in 60 sterile applicators per carton.
Brand
BD ChloraPrep
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers 2272350 or 2301939 on the packaging with expiration date 09/30/2025.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed nationwide to 100 consignees. Please refer to consignee list.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1168-2023 (August 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1168-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.