December 2025 FDA Recall Drug by Stuffbynainax
D-0397-2026 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Stuffbynainax on December 15, 2025 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Product was distributed to 4 customers in the US. and the recall is currently ongoing.

Recall Number: D-0397-2026

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Initiated
12-15-2025
Reported
03-11-2026
Quantity
4

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98256
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.
StuffbyNainax
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 4 customers in the US.
Product Description About Product Description
Full technical description of the product.
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

Batch or Lot Expiration Information

Lot# All codes; Exp 12/31/2029