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.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Fabscout Entertainment, Inc
See all →- CriticalSilver Sword capsules recalled for undeclared sildenafil ingredient
FDA (Drugs) · 2014-03-26
- CriticalClalis capsules recalled for undeclared sildenafil ingredient
FDA (Drugs) · 2014-03-26
- CriticalEvil Root 1200 mg Recalled for Undeclared Sildenafil
FDA (Drugs) · 2013-12-25
- CriticalPRO POWER MAX Energy Capsules Recalled for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2013-12-25
Same hazard · undeclared sildenafil
See all →- SevereZapMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
FDA (Drugs) · 2024-12-11
- SevereVitalityXtra Capsules Recalled for Undeclared Sildenafil and Diclofenac
FDA (Drugs) · 2024-12-11
- SeverePeakMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
FDA (Drugs) · 2024-12-11
- SevereGold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil
FDA (Drugs) · 2024-10-09
- SevereHard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
FDA (Drugs) · 2024-10-09
Similar recalls
- SevereDietary Supplement Tainted with Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2025-03-26
- SevereUnapproved Drug Capsule Recalled for Undeclared Sexual Enhancement Ingredients
FDA (Drugs) · 2023-05-10
- SevereDietary supplement found to contain undeclared pharmaceutical drug tadalafil
FDA (Drugs) · 2022-07-27
- SevereForeverMen Natural Energy Boost Capsules Recalled for Undeclared Sildenafil
FDA (Drugs) · 2024-05-01
- CriticalSilverback XXX Power male enhancement product recalled for undeclared sildenafil and tadalafil
FDA (Drugs) · 2024-05-01
- SevereUnapproved Male Enhancement Supplements Containing Tadalafil Recalled Nationwide
FDA (Drugs) · 2013-05-22