Recalls / Class I
Class ID-0397-2026
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
- Affected lot / code info
- All codes; Exp 12/31/2029
Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Recalling firm
- Firm
- StuffbyNainax
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2830 Lake Rd Apt 1102, N/A, Huntsville, Texas 77340-5662
Distribution
- Quantity
- 4
- Distribution pattern
- Product was distributed to 4 customers in the US.
Timeline
- Recall initiated
- 2025-12-15
- FDA classified
- 2026-03-18
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0397-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.