Fungus found in a skin antiseptic used before procedures, covering over 190,000 applicators — the paradox of contamination in something that must be sterile
BD ChloraPrep Clear skin antiseptic applicators made by CareFusion 213 (2% chlorhexidine gluconate with 70% isopropyl alcohol) were recalled for non-sterility due to the presence of the fungus Aspergillus penicillioides. Classification is Class I and 193,440 applicators are covered.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeDrug
- Recalling firmCareFusion 213, LLC
- ReasonNon-Sterility: Due to presence of Aspergillus penicillioides.
- DistributionNationwide inthe USA, as well as other foreign distribution.
- Recall initiated2026-05-28
Key points
- BD ChloraPrep Clear skin antiseptic applicators (2% chlorhexidine with 70% isopropyl alcohol) were recalled for non-sterility.
- The reason is the presence of the fungus Aspergillus penicillioides. Classification is Class I, the most serious level.
- 193,440 applicators are covered. Recall initiation was 2026-05-28 and the report date 2026-07-01.
- Of the 1,408 records this site holds as of 2026-09-02, 353 involve sterility or microbial contamination — the most common reason.
- Distribution was nationwide in the United States and abroad, and the recall was firm-initiated.
1A product for preventing contamination, contaminated
Skin antiseptic applicators are used to reduce skin flora before an injection, a surgical procedure or the insertion of a catheter. Given that purpose, a product that is not itself sterile loses its point. This recall is exactly that premise breaking down: the fungus Aspergillus penicillioides was found in the product.
2Sterility, the most common reason of all
Counting the words that appear in recall reasons across the 1,408 FDA records this site holds as of 2026-09-02, sterility and microbial contamination stand well clear at 353. The type spans both drugs and devices, and can arise at the environmental, raw-material or packaging stage of manufacturing.
3What the quantity means
The recall covers 193,440 applicators. Single-use antiseptic products are consumed one per procedure, so the count doubles as a rough measure of procedures. Recall initiation was 2026-05-28 and the record was reported on 2026-07-01. Recall records carry both dates, and the gap shows the time between product beginning to be pulled from the field and the case being entered into the public record.
4Who begins a recall
This case too was initiated voluntarily by the firm. Of the 1,408 records this site holds as of 2026-09-02, 1,392 were firm-initiated and 8 were FDA-mandated. Sterility problems are most often detected by the manufacturer own quality testing and environmental monitoring. For products in use, follow healthcare professionals and the official information from the FDA and the manufacturer.
Why it matters
Contamination in a product that sits at the start of infection control can carry through to every procedure downstream. Together with sterility being the most common recall reason, it shows environmental control in sterile manufacturing as a foundation of clinical quality.
FAQ
How does an antiseptic product become contaminated?
Why do the initiation and report dates differ?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0624-2026