BD PurPrep Recall Due to Potential Sterility Issues
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 has initiated a voluntary recall of BD PurPrep sterile solution due to lack of assurance of sterility and potential product contamination.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 24, 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 due to lack of assurance of sterility and potential product contamination.
Which Products Are Affected
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton (NDC 54365-014-42). Affected lots include: 4258309, 4260329, 4256875 (Exp. 08-31-2026); 4296453, 4317319, 4290654 (Exp. 09-30-2026); 4322449, 4323861, 4318679 (Exp. 10-31-2026). Distributed nationwide in the USA.
What You Should Do
Consumers should refer to the FDA recall notice for further guidance on the affected product.
Why This Matters
This Class II recall addresses a potential sterility issue with a topical antiseptic product distributed nationwide.
Source
FDA recall number D-0517-2026 (https://www.fda.gov)
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 (847 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 24, 2026.
Frequently Asked Questions
Common questions about this FDA recall.