BD ChloraPrep Clear Recall Due to Sterility Concerns
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 146,600 units of BD ChloraPrep Clear applicators nationwide due to lack of assurance of sterility.
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 to customers outside the intended distribution 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 (IPA)), packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB. A total of 146,600 units are affected. Specific lots include (a) 3214024, 3199359, 3200136 (Exp 6/30/2026), 3212372 (Exp. 7/31/2026), 3237018, 3243267, 3264290 (Exp. 8/31/2026), 3313291 (Exp. 10/31/2026), 3334121 (Exp. 11/30/2026), 4030693, 4033380 (Exp 1/31/2027), and many additional lots through 6061876 (Exp. 2/28/2029); (b) 3293904 (Exp. 10/31/2026), 3333265 (Exp. 11/30/2026), and additional lots through 5165652 (Exp. 6/30/2028). Distributed nationwide in the USA. Recall number D-0645-2026. Class II recall.
What You Should Do
Consumers should verify lot numbers against the recalled lots listed by the FDA.
Why This Matters
This Class II recall involves a sterility assurance issue for a topical antiseptic product distributed across the United States.
Source
FDA recall D-0645-2026, report date 20260708.
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 (1,386 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.