Recall Record

Tempe, AZ, United States

SAINI TRADE INC recalls

1 recall recorded since 2018, most recently on 14 April 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
14 April 2025
Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Distribution
Nationwide
Initiated
Voluntary: Firm initiated
Recall numbers
D-0465-2025, D-0466-2025, D-0467-2025, D-0464-2025, D-0463-2025

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.