BD ChloraPrep Clear Recall Due to Sterility Issue
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 18,000 units of BD ChloraPrep Clear applicators distributed nationwide due to lack of sterility assurance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 2026 and geographically references United States. Its severity classification of "medium" 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 because unsterilized ChloraPrep applicators intended for further processing and sterilization were distributed outside the intended channel, resulting in a lack of assurance of sterility.
Which Products Are Affected
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 500 x 1 mL applicators/case, STERILE SOLUTION. NDC 54365-400-31, bulk catalog number 930480NSB. Quantity: 18,000 units. Lots: 4088933 (Exp 03/31/2027), 4177711, 4195438 (Exp 06/30/2027), 5051114 (Exp 02/29/2028), 5070540 (Exp 03/31/2028), 5106254 (Exp 04/30/2028), 5141607 (Exp 05/31/2028), 5196494 (Exp 07/31/2028). Distributed nationwide in the USA. Recall number D-0651-2026. Classification: Class II. Status: Ongoing.
What You Should Do
Consumers should verify lot numbers against the listed affected lots and contact the recalling firm for additional guidance.
Why This Matters
The recall affects 18,000 units distributed across the United States and involves a topical antiseptic product where sterility cannot be assured.
Source
FDA recall D-0651-2026, CareFusion 213, LLC, El Paso, TX.
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 (1,181 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.