D-0397-2026 Class I Ongoing
FDA drug recall D-0397-2026 was initiated by StuffbyNainax on December 15, 2025 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil The recall status is ongoing. Affected quantity: 4.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- December 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
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
Distribution Pattern
Product was distributed to 4 customers in the US.
Code Information
All codes; Exp 12/31/2029