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FDA · DrugsClass I

StuffbyNainax drug recall: MR. 7 SUPER 700000 capsules

Undeclared allergens

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Drugs
Classification
Class I
Status
Ongoing
Event ID
98256
Recall initiated
Dec 15, 2025
Classified by FDA
Mar 18, 2026
Posted in Enforcement Report
Mar 11, 2026
Recalling firm
StuffbyNainax
Firm location
Huntsville, TX, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Press Release
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Dec 15, 2025. FDA classified it 93 days later, on Mar 18, 2026. Distribution reported by FDA: Product was distributed to 4 customers in the US.

Recalled products (1)

  • D-0397-2026 Class I Ongoing

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

    Codes / lots: All codes; Exp 12/31/2029

    Quantity: 4

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
Official notice
FDA Enforcement Report, event 98256
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.