D-0396-2026 Class I Ongoing
FDA drug recall D-0396-2026 was initiated by Mohamed Hagar on October 8, 2025 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule). The recall status is ongoing. Affected quantity: 125 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- October 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 boxes
Product Description
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 Pattern
U.S. Nationwide
Code Information
ALL LOTS, exp 12/31/2027