FDA DrugsClass I
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Published: March 11, 2026Recall ID: D-0397-2026Category: drugsCountry: US
Reason for Recall / Hazard
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Product Description & Identification
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Additional Source Details
| Field | Value |
|---|---|
| City | Huntsville |
| State | TX |
| Event id | 98256 |
| Address 1 | 2830 Lake Rd Apt 1102 |
| Address 2 | N/A |
| Code info | All codes; Exp 12/31/2029 |
| Postal code | 77340-5662 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 4 |
| Reason for recall | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Press Release |
| Center classification date | 20260318 |
Overview
- Recalling FirmStuffbyNainax
- StatusOngoing
- Risk LevelClass I
- DistributionProduct was distributed to 4 customers in the US.