FDA Recalls Espumil Lipophilic Foam Base for Labeling Issue
Letco Medical LLC recalls Espumil Lipophilic foam base (batch 24G15-T02-115604) distributed to compounding pharmacies due to a labeling issue. The recall affects 173 bottles of 500 ml.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported health hazard, illness, or injury. The stated issue is a labeling classification problem, which constitutes a documentation or compliance matter rather than a patient safety risk.
Plain-English summary
Letco Medical LLC is recalling Espumil Lipophilic foam base, 500 ml bottles (batch 24G15-T02-115604, expiring 11/30/2026), distributed to 44 compounding pharmacies and 2 distributors. The recall has been issued due to a labeling classification issue.
The affected product totals 173 bottles, 500 ml each. Distribution was directed to Letco Medical, LLC (Decatur, AL) and further distributed through the supply chain to the compounding pharmacy network.
Compounding pharmacies that received this product should identify affected inventory by batch number. The FDA has classified this as a Class III recall.
The recalled product
- Product
- Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
- Manufacturer
- Letco Medical LLC
- Hazard
- labeling-issue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 24G15-T02-115604
- exp. 11/30/2026
Distribution
Distributed in 1 state:
- AL
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