Exact FDA event identifier

Event 97660

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

Event summary

Timeline bucket: September 12, 2025
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Letco Medical LLC

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

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

D-0138-2026

Recall number: D-0138-2026
Initiated: September 12, 2025
Classification: Class III
Status: Ongoing
Recalling firm: Letco Medical LLC
Quantity: 173 500 ml bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Labeling: Not Elsewhere Classified

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified

Code information

Batch # 24G15-T02-115604, exp. 11/30/2026

Distribution pattern

Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors.