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Recall Observatory FDA recall evidence

Drug product

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

D-0397-2026

December 15, 2025

Class I

Product summary

Firm
StuffbyNainax
Event
Event 98256
Status
Ongoing
Classification
Class I
Quantity
4
Official record key
drug-enforcement:D-0397-2026

Official wording

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

Code information: All codes; Exp 12/31/2029

Distribution pattern: Product was distributed to 4 customers in the US.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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