FDA Drug recall D-0441-2025
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Steri…
- FDA Drug
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Steri… by Carefusion 213, citing lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0441-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-15 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Carefusion 213 |
| Distribution | US |
Product
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Reason
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Identifiers
| ndc | 54365-400-31 |
|---|---|
| code_info | Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Carefusion 213
- BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) e…
FDA Drug · Class II · 2026-07-22 · Carefusion 213 - BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/cas…
FDA Drug · Class II · 2026-07-08 · Carefusion 213 - BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUT…
FDA Drug · Class II · 2026-07-08 · Carefusion 213 - BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, Ca…
FDA Drug · Class II · 2026-07-08 · Carefusion 213 - BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION,…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0441-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.