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 over 43 million units of BD ChloraPrep Clear applicators nationwide due to potential lack of sterility from open or incomplete seals.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 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 of BD ChloraPrep Clear due to lack of assurance of sterility. Affected product may exhibit an open or incomplete seal on the packaging of the applicator.
Which Products Are Affected
The recall covers BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03 fl oz (1 mL) each, sterile solution, NDC 54365-400-31. A total of 43,066,599 units distributed nationwide in the U.S.A. are affected. Specific lots include: 4062535, 4065201, 4066446 (Exp. 2/28/2027); 4141090 (Exp. 5/31/2027); 4180288, 4197695, 4197697, 4180291 (Exp. 6/30/2027); and numerous additional lots through 6111107 (Exp. 4/30/2029). Recall number D-0690-2026. Classification: Class II.
What You Should Do
Consumers should verify lot numbers against the recalled list and contact CareFusion 213, LLC at 1550 Northwestern Dr, El Paso, TX 79912-8000 for further instructions.
Why This Matters
The recall involves a large volume of a widely distributed topical antiseptic product used in healthcare settings across the United States.
Source
FDA recall D-0690-2026, report date 20260722.
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 (1,199 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.