FDA Recall D-0138-2026
Letco Medical LLC · Decatur, AL
Class III Ongoing 244 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Reason for recall
Labeling: Not Elsewhere Classified
Recall record
- Recall number
D-0138-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- 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.
- Recall initiated
- 2025-09-12
- Classified by FDA Center
- 2025-10-29
- FDA published
- 2025-11-05
- Recalling firm
- Letco Medical LLC
- Firm location
- Decatur, AL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.