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.
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.