Recall Record

Decatur, AL, United States

Letco Medical LLC recalls

2 recalls recorded since 2018, most recently on 12 September 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0

Ongoing Class III Drugs

Recall started
12 September 2025
Reason
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.
Initiated
Voluntary: Firm initiated
Recall number
D-0138-2026

Terminated Class II Drugs

Recall started
10 January 2020
Terminated
7 April 2021
Reason
Subpotent
Distribution
United States, Australia, Canada, Israel, Philippines, Taiwan.
Initiated
Voluntary: Firm initiated
Recall number
D-0780-2020

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.