BD PurPrep 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 specific lots of BD PurPrep antiseptic solution due to potential lack of sterility assurance.
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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
CareFusion 213, LLC initiated a voluntary recall of BD PurPrep 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, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. NDC 54365-014-41. Affected lots: 4263873 (Exp. Date 08-31-2026), 4320590 (Exp. Date 09-30-2026), 4320591 (Exp. Date 10-31-2026). Distributed nationwide in the USA. Recall number D-0518-2026.
What You Should Do
Consumers should check product lots against the affected codes listed above.
Why This Matters
This Class II recall addresses a potential contamination risk in a topical antiseptic product distributed across the United States.
Source
FDA recall D-0518-2026 (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts)
Original source: FDA Official Notice ↗
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