MR. 7 Super capsules recalled as Class I over undeclared sildenafil
StuffbyNainax is recalling MR. 7 SUPER 700000 capsules because FDA analysis revealed the presence of undeclared sildenafil and tadalafil. The FDA has classified this recall as Class I.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
StuffbyNainax is recalling MR. 7 SUPER 700000 capsules, supplied as a one-capsule blister card, distributed by mR. 7. Four units were distributed to four customers in the United States.
The product was marketed without an approved New Drug Application or Abbreviated New Drug Application, and FDA analysis revealed the presence of undeclared sildenafil and tadalafil. The FDA has classified this recall as Class I, its most serious category.
All codes are affected, with an expiry date of 12/31/2029.
Consumers can identify affected product by the product name and expiry date above, and may contact StuffbyNainax for further information.
The recalled product
- Product
- MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
- Manufacturer
- StuffbyNainax
- Category
- Drug — Dietary supplement
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All codes
- Exp 12/31/2029
Distribution
Distribution scope not specified by the agency.
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