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Class IIDrug recallOngoing

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

  1. 05/28/2026Firm started the recall
  2. 06/25/2026FDA classified it as Class II
  3. 07/01/2026Published in the FDA enforcement report

All products in this recall

4 products under event 99114

More recalls from CareFusion 213

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