Why it was recalled
Lack of assurance of Sterility: potential product contamination
Product description
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Lot numbers, UPCs & expiration codes
Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
Where it was sold
Nationwide in the USA
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-0517-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 22, 2026
- FDA report date
- May 13, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-0517-2026, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 98790
- Address
- 1550 Northwestern Dr
- Code information
- Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
- Postal code
- 79912-8000
- Report date
- May 13, 2026
- Product type
- Drugs
- Recall number
- D-0517-2026
- Classification
- Class II
- Recalling firm
- CareFusion 213, LLC
- Reason for recall
- Lack of assurance of Sterility: potential product contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 22, 2026
- Initial firm notification
- Letter
- Center classification date
- May 5, 2026