Exact FDA event identifier

Event 97486

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

Event summary

Timeline bucket: August 19, 2025
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Medline Industries, LP

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

READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25

D-0674-2025

Recall number: D-0674-2025
Initiated: August 19, 2025
Classification: Class III
Status: Ongoing
Recalling firm: Medline Industries, LP
Quantity: 2,680 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot # 24EJA180, Exp 06/01/2027

Distribution pattern

Nationwide in the USA