FDA recall D-0396-2026

Mohamed Hagar · Class I · drug

Product

Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0

Reason for recall

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

Key facts

Status: Ongoing
Initiation date: 2025-10-08
Report date: 2026-03-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooklyn Ctr, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0396-2026