Dietary Supplement Recalled for Undeclared Sildenafil and Lack of FDA Approval
Fabscout Entertainment is recalling 72HP Maximum Potency Male Sexual Enhancement because it contains undeclared sildenafil and was marketed without FDA approval.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Fabscout Entertainment, Inc. is recalling 72HP Maximum Potency Male Sexual Enhancement, a dietary supplement. The product is supplied in single-capsule blister packs and was distributed by 72HP, Inc. in Weston, Florida.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was found to contain undeclared sildenafil, a prescription medication.
The recall affects 578 blister packs of 1 capsule each. The product was distributed in California, Florida, and Utah. All lots are included in this recall. Consumers should stop using the product and contact the distributor for instructions on return or disposal.
The recalled product
- Product
- 72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL
- Manufacturer
- Fabscout Entertainment, Inc
- Category
- Drug — Dietary Supplement
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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Fabscout Entertainment, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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