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BD ChloraPrep Clear recall
Recalled by CareFusion 213, LLC · Part of Becton Dickinson & Co of El Paso, TX · FDA report 07/01/2026
Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.
- Class
- Class II
- Moderate
- Status
- Ongoing
- Recall started
- 05/28/2026
- Distribution
- Nationwide
Reason for recall
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Recalled product
- Product
- BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
- Lot and code info
- Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4038825, 4038826, 4043641, 4045863, 4046559, Exp Date: 1/31/2027; Lot # 4049128, 4060484, 4061622, 4062534, Exp Date: 02/28/2027; Lot # 4072323, 4081465, 4092172, 4092053, 4092057, 4093448, 4096267, 4099351, Exp Date: 03/31/2027; Lot # 4106830, 4106833, 4106834, 4123769, 4123637, 4124547, 4123599, 4131749, Exp Date: 04/30/2027; Lot # 4137704, 4139447, Exp Date: 05/31/2027
- Brand names
- CHLORAPREP ONE-STEP
- Recall number
- D-0622-2026
- Event ID
- 99114
- Initiated by
- Voluntary: Firm initiated
Where it was distributed
Nationwide inthe USA, as well as other foreign distribution.
- Nationwide
Recall timeline
- 05/28/2026Firm started the recall
- 06/25/2026FDA classified it as Class II
- 07/01/2026Published in the FDA enforcement report
All products in this recall
4 products under event 99114
- D-0622-2026BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care... This page
- D-0623-2026BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution...
- D-0624-2026BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile...
- D-0625-2026BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution...
More recalls from CareFusion 213
- Class IIDrugOngoing07/22/2026BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL...CareFusion 213, LLC · Lack of Assurance of Sterility: Affected product may exhibit an...
- Class IIDrugOngoing07/08/2026BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA))...CareFusion 213, LLC · 10 products · Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep...
- Class IIDrugOngoing05/13/2026BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile...CareFusion 213, LLC · 2 products · Lack of assurance of Sterility: potential product contamination
- Class IIDrugOngoing01/07/2026BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70%...CareFusion 213, LLC · Lack of Assurance of Sterlity
- Class IIDrugOngoing05/28/2025BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient...CareFusion 213, LLC · Lack of Assurance of Sterility: The affected product may exhibit...
- Class IDrugOngoing03/19/2025BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol...CareFusion 213, LLC · Non-Sterility: contamination of Aspergillus penicillioides, due to...
Frequently asked questions
- Why was BD ChloraPrep Clear recalled?
- Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- What does Class II mean?
- Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Where was the recalled product sold?
- Nationwide inthe USA, as well as other foreign distribution.
- Is this recall still active?
- The FDA lists the recall as ongoing. The recall is still in progress.
Subsidiary of Becton Dickinson & Co (BDX) · financials and records from other agencies
Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 07/01/2026 · Do not rely on openFDA to make decisions regarding medical care