October 2025 FDA Recall Drug by Mohamed Hagar (D-0396-2026 - Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).)

This Class I drug recall was voluntarily initiated by Mohamed Hagar on October 8, 2025 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda-fda analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0396-2026

Reason for Recall
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Initiated
10-08-2025
Reported
03-11-2026
Quantity
125 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97796
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mohamed Hagar
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# ALL LOTS, exp 12/31/2027