Povi-One Oral Antiseptic Recall Due to Sub Potency
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub potency. The voluntary recall affects specific lots distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 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, drug.
What Happened
Elevate Oral Care initiated a voluntary recall of Povi-One due to sub potency.
Which Products Are Affected
Povi-One, 10% Povidone-Iodine Oral Antiseptic, packaged by Elevate Oral Care, LLC, NDC 57511-0611-1. Affected lots: PO062402 (Exp 6/30/2026), PO072401 (Exp 7/30/2026), PO092401 (Exp 9/30/2026), PO102401 (Exp 10/31/2026), PO102402 (Exp 10/31/2026). Quantities: 8132 6-packs and 2262 2-packs. Distribution: Nationwide. Recall number: D-0627-2026. Classification: Class II.
What You Should Do
Consumers should contact the recalling firm for further information regarding the recall.
Why This Matters
The recall involves over 10,000 packs of the topical antiseptic product distributed across the United States.
Source
FDA recall D-0627-2026, 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 (797 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.