Recall: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
This page indexes a United States Food and Drug Administration (FDA) enforcement report describing a drug recall associated with Carefusion 213, LLC. The recalled item is described in the source record as BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.. The FDA assigned this recall a regulatory classification of Class I, and the recall is currently recorded with a status of Ongoing. The recall is identified in FDA systems by recall number D-0625-2026. The recalling firm is associated with TX, United States in the source record. This recall record was published on 2026-07-01. Every field on this page is reproduced as a regulatory data point from the official openFDA dataset and is intended to help you locate and verify the original report. It is not a safety instruction, a clinical assessment, or advice about whether to use any product. Confirm all details against the linked FDA source before relying on them.
FDA recall data
| Recall number | D-0625-2026 |
|---|---|
| Event ID | 99114 |
| Classification | Class I (most serious regulatory tier) |
| Status | Ongoing |
| Product description | BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. |
| Recalling firm | Carefusion 213, LLC |
| Distribution pattern | Nationwide inthe USA, as well as other foreign distribution. |
| State | TX |
| Country | United States |
| Report date | 2026-07-01 |
| Recall initiation date | 2026-05-28 |
Reason for recall (source data field)
The following text is the recalling firm's stated reason, reproduced verbatim from the FDA enforcement report as a regulatory data field. It is presented for identification and verification only — it is not a safety instruction, a clinical assessment, or advice.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
How to interpret this recall record
A recall record means a firm has removed or corrected a marketed product in cooperation with the FDA, and that the agency has logged the action in its enforcement reports. The classification (Class I) is the FDA's regulatory severity tier for the action; it describes the agency's assessment of the recall event in administrative terms, not a personalised risk statement for any individual. The status (Ongoing) reflects where the recall sits in its lifecycle. Read this entry as a pointer to an official report: open the linked FDA source to confirm the product, lot scope, dates, and current status before acting on any of it.
What this record does not mean
This recall record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.
Related manufacturer
This recall is attributed to Carefusion 213, LLC. That page aggregates the firm's other indexed recall and shortage records as coverage-limited regulatory signals (not quality ratings).
Related recalls (Class I)
- Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02. · 2026-07-08
- BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. · 2026-07-01
- Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. · 2026-06-17
- BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. · 2026-06-17
- DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. · 2026-06-17
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0625-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-07-01
- Ingested
- 2026-07-28
- Record hash
d7cd45225b277ea4
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.