MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

FDA Recall #D-0397-2026 — Class I — December 15, 2025

Recall #D-0397-2026 Date: December 15, 2025 Classification: Class I Status: Ongoing

Product Description

MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

Reason for Recall

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil

Recalling Firm

StuffbyNainax — Huntsville, TX

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

4

Distribution

Product was distributed to 4 customers in the US.

Code Information

All codes; Exp 12/31/2029

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated