Rhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients
Premiere Sales Group is recalling Rhino 7 3000 bottles because they contain undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.
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 according to the rubric.
Plain-English summary
Premiere Sales Group is recalling 337 bottles of Rhino 7 3000, a 6-count bottle product distributed by Rhino 7 and made in the USA. The recall covers all lots of the product.
The FDA is recalling these products because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the products contain undeclared active pharmaceutical ingredients: desmethyl carbondenafil and dapoxetine.
The recall is distributed nationwide. Consumers who have purchased Rhino 7 3000 should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
- Manufacturer
- Premiere Sales Group
- Category
- Drug — Unapproved Supplement
- Affected units
- 337
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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Premiere Sales Group 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 2 products in this recall →Related recalls
Same manufacturer · Premiere Sales Group
See all →- CriticalRhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients
FDA (Drugs) · 2016-02-24
Same hazard · undeclared ingredients
See all →- CriticalFDA Recalls Addall XR Shot Liquid Dietary Supplement
FDA (Food) · 2026-09-02
- SevereD'Dioses Mango Ice Pops Recalled for Undeclared Allergens
FDA (Food) · 2026-07-22
- ModerateSuper ProTHIN Plus Dietary Supplement Recalled for Undeclared Dyes
FDA (Food) · 2025-07-02
- LowGaiser's Recalls Ready-to-Eat Bologna Due to Undeclared Meat Ingredients
USDA FSIS · 2025-06-27
- HighFlour tortillas recalled due to undeclared wheat allergen
FDA (Food) · 2024-05-29
Similar recalls
- CriticalRhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients
FDA (Drugs) · 2016-02-24
- CriticalRhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients
FDA (Drugs) · 2016-03-16
- CriticalTf Supplements Recalls Rhino 7 3000 Due to Undeclared Ingredients
FDA (Drugs) · 2016-03-16
- CriticalFDA Recalls Rhino 5 Capsules Containing Unapproved Drug Ingredients
FDA (Drugs) · 2014-02-05
- CriticalGadget Island Recalls Unapproved Rhino 7 Platinum 5000 Capsules
FDA (Drugs) · 2017-12-13
- CriticalFDA Recalls Rhino 7 Platinum 30000 Capsules for Unapproved Tadafila Content
FDA (Drugs) · 2020-01-22