Drug & medication recalls High risk

StuffbyNainax product recalled over undeclared sildenafil

Recall date
December 15, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
StuffbyNainax recalls MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Recall number
D-0397-2026
FDA classification
Class I
Brand / firm
StuffbyNainax
Sold / distributed
Product was distributed to 4 customers in the US.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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