Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Product description
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Lot numbers, UPCs & expiration codes
All codes; Exp 12/31/2029
Where it was sold
Product was distributed to 4 customers in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0397-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 15, 2025
- FDA report date
- Mar 11, 2026
- Quantity
- 4
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- StuffbyNainax
Original FDA data
Every field from FDA enforcement report D-0397-2026, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 98256
- Address
- 2830 Lake Rd Apt 1102
- Code information
- All codes; Exp 12/31/2029
- Postal code
- 77340-5662
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0397-2026
- Classification
- Class I
- Recalling firm
- StuffbyNainax
- 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
- Product description
- MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
- Distribution pattern
- Product was distributed to 4 customers in the US.
- Recall initiation date
- Dec 15, 2025
- Initial firm notification
- Press Release
- Center classification date
- Mar 18, 2026