September 2025 FDA Recall Drug by Letco Medical Llc
D-0138-2026 - Labeling

This Class III drug recall was voluntarily initiated by Letco Medical Llc on September 12, 2025 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors. and the recall is currently ongoing.

Recall Number: D-0138-2026

Reason for Recall
Labeling: Not Elsewhere Classified
Initiated
09-12-2025
Reported
11-05-2025
Quantity
173 500 ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97660
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Letco Medical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial 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.
Product Description About Product Description
Full technical description of the product.
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

Batch or Lot Expiration Information

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