Exact FDA event identifier

Event 99191

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 04, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Elevate Oral Care

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.

D-0627-2026

Recall number: D-0627-2026
Initiated: June 04, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Elevate Oral Care
Quantity: 8132 6-packs & 2262 2-packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

sub potency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

sub potency

Code information

Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026.

Distribution pattern

Nationwide