FDA recall D-0397-2026

StuffbyNainax · Class I · drug

Product

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

Distribution

Product was distributed to 4 customers in the US.

Key facts

Status
Ongoing
Initiation date
2025-12-15
Report date
2026-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Huntsville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0397-2026