Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported March 19, 2025
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
CareFusion 213, LLC recalled BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v iso… - a critical-severity action.
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v iso… was recalled by CareFusion 213, LLC in March 19, 2025. Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.. Check the official notice for the remedy. Verify recall #D-0259-2025 with the FDA Drug before acting.
The recall
CareFusion 213, LLC issued this critical-severity FDA Drug recall-Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding..
- Critical
- severity level
- Class I
- classification
- March 19, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0259-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0259-2025) was formally reported on March 19, 2025, with the manufacturer initiating the action on February 14, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. CareFusion 213, LLC is listed as the recalling firm, operating out of El Paso, TX. Federal records list the affected scope as 205,440 applicators.
The documented reason for this recall is: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Distribution data in the federal record shows the product reached: Nationwide and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Cosmetics & Personal Care recalls over time
Where this recall sits in its category - 1,360 cosmetics & personal care recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
205,440 applicators
Related Recalls
6
3 from same agency
Product description
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Reason for recall
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0259-2025 |
| Date reported | March 19, 2025 |
| Date initiated | February 14, 2025 |
| Recalling firm | CareFusion 213, LLC |
| Firm location | El Paso, TX |
| Affected scope | 205,440 applicators |
| Distribution | Nationwide and Canada |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0259-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.. Recalled by CareFusion 213, LLC. Units affected: 205,440 applicators.
Why was this product recalled? ▼
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 19, 2025. Severity: Critical. Recall number: D-0259-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0259-2025) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
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· 2026-06-04
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Compare this recall with Tiny Land Children's Play Tents Recalled Due to Risk of Inj… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 19, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.