Summary
The FDA issued a Class III for Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 by Letco Medical LLC. Reason: Labeling: Not Elsewhere Classified.
Details
Source
Drug Recall
External ID
D-0138-2026
Action Date
2025-11-05
Status
Ongoing
Category
drug
Product Description
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Lot/Code Info: Batch # 24G15-T02-115604, exp. 11/30/2026
Quantity Affected: 173 500 ml bottles
Reason for Recall
Labeling: Not Elsewhere Classified
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-12
Company
Decatur, AL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 95 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Letco Medical LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Letco Medical LLC have FDA actions?
This is the only FDA action we have on record for Letco Medical LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0138-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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