Lipophilic foam base recalled over an unclassified labeling problem
Letco Medical is recalling 173 500 ml bottles of Espumil lipophilic foam base over a labeling issue recorded as not elsewhere classified.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a minor labeling error: the FDA designated this Class III and the record describes a labeling issue with no stated health consequence.
Plain-English summary
Espumil, a lipophilic foam base supplied in 500 ml bottles, batch 24G15-T02-115604, from Letco Medical, is being recalled.
The enforcement record gives the reason as "Labeling: Not Elsewhere Classified" and does not describe the nature of the labeling problem or any health consequence.
The recall covers 173 bottles from batch 24G15-T02-115604, expiring 30 November 2026. The product was distributed to Letco Medical in Decatur, Alabama and further distributed from there. The FDA has classified the recall as Class III, its least serious category.
Compounding pharmacies holding the affected batch should follow the firm's instructions.
The recalled product
- Product
- Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
- Manufacturer
- Letco Medical LLC
- Category
- Drug — Compounding base
- Hazard
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:
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