FDA recall D-0138-2026

Letco Medical LLC · Class III · drug

Product

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

Reason for recall

Labeling: Not Elsewhere Classified

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-09-12
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Decatur, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0138-2026