Recall Record

Brooklyn Ctr, MN, United States

Mohamed Hagar recalls

1 recall recorded since 2018, most recently on 8 October 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
8 October 2025
Reason
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Distribution
U.S. Nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-0396-2026

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.