BD ChloraPrep FREPP Clear, 2% recall — Carefusion 213, LLC (Class I)
Carefusion 213, LLC is recorded by the U.S. Food and Drug Administration (FDA) as recalling BD ChloraPrep FREPP Clear, 2% — a Class I recall, initiated 2026-05-28 and posted to the FDA enforcement report on 2026-07-01, under recall number D-0625-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “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.”. From the product description, the form is solution and the strengths given are 2%, 70% and 1.5 mL. 1 National Drug Code number is printed in the record: 54365-400-30. Distribution is recorded as “Nationwide inthe USA, as well as other foreign distribution” — Nationwide (US), with the recalling firm on record in TX, United States. The FDA files it under event ID 99114 together with 3 other recall numbers, all listed and linked below. Within that event this is the strength 2% · 70% · 1.5 mL, ndc 54365-400-30 and product named BD ChloraPrep FREPP Clear configuration; the sibling records differ on strength, ndc, product named and fda tier, and 1 more and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0625-2026 |
|---|---|
| FDA event ID | 99114 (4 recall numbers) |
| Classification | Class I (most serious regulatory tier) |
| Status | Ongoing |
| Recalling firm | Carefusion 213, LLC |
| Recall initiated | 2026-05-28 |
| Reported by FDA | 2026-07-01 |
| Report lag | 34 days from initiation to report |
| Distribution | Nationwide inthe USA, as well as other foreign distribution. — Nationwide (US) |
| Firm location on record | TX, United States |
| Product description (source) | 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. |
Reason reported by FDA
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.
26 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.
Product identifiers in this record
5 identifying values matched by exact pattern in the 37-word product description above; each is a literal substring of it.
| Product named | BD ChloraPrep FREPP Clear |
|---|---|
| Form | Solution |
| Strength | 2% · 70% · 1.5 mL |
| NDC | 54365-400-30 |
Which configuration this record is
4 recall numbers share event 99114. They differ on strength, ndc, product named, fda tier and reason text and agree on everything else the source states, so those are the values to check a package against.
| Attribute | This record (D-0625-2026) | D-0622-2026 | D-0623-2026 | D-0624-2026 |
|---|---|---|---|---|
| Strength | 2% · 70% · 1.5 mL | 2% · 70% · 1 mL | 2% · 70% · 1.5 mL | 2% · 70% · 1 mL |
| NDC | 54365-400-30 | 54365-400-31 | 54365-400-30 | 54365-400-31 |
| Product named | BD ChloraPrep FREPP Clear | BD ChloraPrep Clear | BD ChloraPrep FREPP Clear | BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) |
| FDA tier | Class I | Class II | Class II | Class I |
| Reason text | 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. | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | Non-Sterility: Due to presence of Aspergillus penicillioides. |
Shared across all 4 records under this event: form Solution; recalling firm Carefusion 213, LLC; initiated 2026-05-28; reported 2026-07-01.
Event context: 4 recall numbers under event 99114
One enforcement action, 4 recall numbers: the FDA filed 3 further configurations of this action under event 99114. Each keeps its own recall number and dates.
| Recall record | Recall number | FDA tier | Strength / form | NDC | Reported |
|---|---|---|---|---|---|
| BD ChloraPrep Clear, 2% | D-0622-2026 | Class II | 2% · Solution | 54365-400-31 | 2026-07-01 |
| BD ChloraPrep FREPP Clear, 2% | D-0623-2026 | Class II | 2% · Solution | 54365-400-30 | 2026-07-01 |
| BD ChloraPrep Clear, 2% | D-0624-2026 | Class I | 2% · Solution | 54365-400-31 | 2026-07-01 |
Other indexed recalls from Carefusion 213, LLC
17 indexed records name Carefusion 213, LLC as the recalling firm, across 4 FDA events, reported 2026-05-13 to 2026-07-22. A coverage-limited activity count over the ingested window, not a quality rating.
| Recall record | Recall number | FDA tier | Strength / form | Reported |
|---|---|---|---|---|
| BD ChloraPrep Clear, 2% | D-0690-2026 | Class II | 2% · Solution | 2026-07-22 |
| BD ChloraPrep Hi-Lite Orange, 2% | D-0643-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD PurPrep, 8.3% | D-0644-2026 | Class II | 8.3% · Solution | 2026-07-08 |
| BD ChloraPrep Clear, 2% | D-0645-2026 | Class II | 2% · Solution | 2026-07-08 |
| ChloraPrep FREPP, 2% | D-0646-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD ChloraPrep Hi-Lite Orange, 2% | D-0647-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD ChloraPrep Hi-Lite Orange, 2% | D-0648-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD ChloraPrep Scrub Teal, 2% | D-0649-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD ChloraPrep Scrub Teal, 2% | D-0650-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD ChloraPrep CLear, 2% | D-0651-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD ChloraPrep CLear, 2% | D-0652-2026 | Class II | 2% · Solution | 2026-07-08 |
| BD PurPrep, 8.3% | D-0517-2026 | Class II | 8.3% · Solution | 2026-05-13 |
Reported in the same month (2026-07)
111 enforcement reports carry a report date in 2026-07; these 2 are the Class I ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| Revitaderm Wound Care Gel, 0.1% | D-0692-2026 | Blaine Labs Inc | Class I | 2026-07-08 |
| Cetirizine Hydrochloride Tablets USP 5 mg | D-0732-2026 | JB Chemicals And Pharmaceuticals Ltd | Class I | 2026-07-29 |
Reading this record
Class I is the FDA's own severity tier for the recall action — 11 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99114 returns all 4 of these recall numbers; a search on D-0625-2026 returns only this configuration. Match a package against 54365-400-30 at the FDA source to confirm it is covered.
Namespace context: the Class I index (11 records) and the recall hub (250 records, 118 FDA events); Carefusion 213, LLC (17 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0625-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.
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
- 2026-08-22
- Record hash
d7cd45225b277ea4
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.