Information
Letco Medical LLC Recalls Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0138-2026Drug / Pharmaceutical
Letco Medical LLC Recalls Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Letco Medical LLC · Class III — Regulatory
Product Description
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Reason for Recall
Labeling: Not Elsewhere Classified
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Letco Medical LLC on September 12, 2025. Labeling: Not Elsewhere Classified. This recall covers 173 500 ml bottles, distributed nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.