BD ChloraPrep FREPP Clear Recall Issued by FDA
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
CareFusion 213, LLC is recalling 178,000 BD ChloraPrep FREPP Clear applicators due to non-sterility from Aspergillus penicillioides and potential seal breaches.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 4, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
CareFusion 213, LLC initiated a voluntary recall of BD ChloraPrep FREPP Clear applicators after the products were found to be non-sterile due to the presence of Aspergillus penicillioides and a lack of assurance of sterility from wrinkles in the paper lidding that may breach the seal area.
Which Products Are Affected
The recall affects 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, distributed by Care Fusion 213, LLC, El Paso, TX 79912. NDC: 54365-400-30. Lot # 4073005, Exp 03/31/2027. A total of 178,000 applicators are affected. Distribution was nationwide in the USA as well as foreign markets.
What You Should Do
Consumers should verify the lot number on any BD ChloraPrep FREPP Clear applicators in their possession against the recalled lot # 4073005.
Why This Matters
This Class I recall addresses potential contamination that could compromise product sterility in a topical antiseptic used in healthcare settings.
Source
FDA recall number D-0625-2026, CareFusion 213, LLC.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,124 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 4, 2026.
Frequently Asked Questions
Common questions about this FDA recall.