Recalls / Class III

Class IIID-0138-2026

Product

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

Affected lot / code info

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

Why it was recalled

Labeling: Not Elsewhere Classified

Recalling firm

Firm

Letco Medical LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1316 Commerce Dr, N/A, Decatur, Alabama 35601-7539

Distribution

Quantity

173 500 ml bottles

Distribution pattern

Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors.

Timeline

Recall initiated

2025-09-12

FDA classified

2025-10-29

Posted by FDA

2025-11-05

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0138-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.