Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 recall
FDA recall D-0138-2026 · initiated Sep 12, 2025
Letco Medical LLC recalled Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 in Sep 2025 — an FDA Class III recall (D-0138-2026) because Labeling: Not Elsewhere Classified.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Not Elsewhere Classified
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 173 500 ml bottles
Details
- Product
- Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
- Recalling company
- Letco Medical LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- 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.
- Initiated
- Sep 12, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 recalled?
- Letco Medical LLC recalled Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 in Sep 2025 — an FDA Class III recall (D-0138-2026) because Labeling: Not Elsewhere Classified. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 recalled?
- Per the FDA enforcement record, the reason for recall D-0138-2026 was: Labeling: Not Elsewhere Classified
- Is a recalled Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 are affected?
- Distributed: Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors.. The recall covers these lots — Batch # 24G15-T02-115604, exp. 11/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0138-2026.