Recall Record

Huntsville, TX, United States

StuffbyNainax recalls

1 recall recorded since 2018, most recently on 15 December 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1

Ongoing Class I Drugs

Recall started
15 December 2025
Reason
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Distribution
Product was distributed to 4 customers in the US.
Initiated
Voluntary: Firm initiated
Recall number
D-0397-2026

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.