Urgent site urgencyFDA Class I

MR

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

Agency
FDA Drug
Recall date
Dec 15, 2025
Status
Ongoing
Company
StuffbyNainax

1. What product was recalled?

MR

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

Quantity: 4

Code or lot text: All codes; Exp 12/31/2029

LOT
All codes
LOT
Exp 12/31/2029
RECALL-NUMBER
D-0397-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Product was distributed to 4 customers in the US.

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Drug source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.