Mojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
Mojo Max Fusion XXX capsules are being recalled because FDA analysis revealed undeclared sildenafil at 13.1 mg per capsule and tadalafil at 13.8 mg per capsule. 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
Mohamed Hagar is recalling Mojo Max Fusion XXX, 500 mg, supplied as one capsule per blister card in 20-count boxes, distributed by Max Nutrition Inc., UPC 678945366750. About 125 boxes were distributed nationwide in the United States.
The product was marketed without an approved New Drug Application or Abbreviated New Drug Application, and FDA analysis revealed undeclared sildenafil at 13.1 mg per capsule and tadalafil at 13.8 mg per capsule. The FDA has classified this recall as Class I, its most serious category.
All lots are affected, with an expiry date of 12/31/2027.
Consumers can identify affected product by the UPC and expiry date above, and may contact the recalling firm for further information.
The recalled product
- Product
- Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
- Manufacturer
- Mohamed Hagar
- Category
- Drug — Dietary supplement
- Affected units
- 125
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 LOTS
- exp 12/31/2027
Distribution
Distributed nationwide across the United States.
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