FDA recall, , Moderate risk
BD ChloraPrep Clear
BD ChloraPrep Clear may have an open or incomplete seal on the applicator packaging.
Summary by Recall Canary from the FDA notice
What happened
CareFusion 213, LLC, of El Paso, Texas, recalled BD ChloraPrep Clear, a sterile solution containing 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, because affected product may exhibit an open or incomplete seal on the packaging of the applicator. The company began the recall on July 9, 2026, and the FDA added it to the Enforcement Report on July 15, 2026.
The product, sold in cartons of 60 x 1 mL applicators, was distributed nationwide in the U.S.A. The recall, involving 43,066,599 units, was classified by the FDA on July 15, 2026, and in the FDA's weekly enforcement report on July 22, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
BD ChloraPrep Clear
- NDC
- 54365-400-31
- Lot code
- 4062535
- 4065201
- 4066446
Recall details
- Company began the recall
- Sold in
U.S.A. Nationwide
- Company
- CareFusion 213, LLCEl Paso, Texas
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99377
- Recall number
- D-0690-2026
- Quantity recalled
- 43,066,599 units
All recalls from CareFusion 213, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
