Why it was recalled
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product description
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Lot numbers, UPCs & expiration codes
Lot # 4073005, Exp 03/31/2027
Where it was sold
Nationwide inthe USA, as well as other foreign distribution.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0625-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- May 28, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- 178,000 applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-0625-2026, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 99114
- Address
- 1550 Northwestern Dr
- Code information
- Lot # 4073005, Exp 03/31/2027
- Postal code
- 79912-8000
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0625-2026
- Classification
- Class I
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 178,000 applicators
- Reason for recall
- Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
- Distribution pattern
- Nationwide inthe USA, as well as other foreign distribution.
- Recall initiation date
- May 28, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2026