MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Summary
The FDA issued a Class I for MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 by StuffbyNainax. Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil.
Details
Source
Drug Recall
External ID
D-0397-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
Product Description
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Lot/Code Info: All codes; Exp 12/31/2029
Quantity Affected: 4
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Distribution
Product was distributed to 4 customers in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-15
Company
Huntsville, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (StuffbyNainax) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does StuffbyNainax have FDA actions?
This is the only FDA action we have on record for StuffbyNainax in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0397-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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