The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1045-2014·Announced 2014-02-05

FDA Recalls Rhino 5 Capsules Containing Unapproved Drug Ingredients

FDA is recalling Rhino 5 capsules marketed as a dietary supplement because they contain undeclared desmethyl carbondenafil and dapoxetine, making them unapproved new drugs.

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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Rhino 5 capsules, which are marketed as a dietary supplement. The product is distributed by P&A Enterprise in Buena Park, California, and manufactured by SS Wholesale Inc. dba Jobbers Wholesale. The recall involves 2,395 blister packs total, with distribution limited to California.

FDA analysis found that the product contains undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitor, a class of drugs used to treat male erectile dysfunction. The presence of these undeclared active ingredients makes the product an unapproved new drug rather than a dietary supplement. The source text does not specify the full status of dapoxetine approval or report any specific illnesses or injuries associated with the product.

Consumers who have purchased Rhino 5 capsules should stop using the product and contact the distributor or manufacturer for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

The recalled product

Product
Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3.
Manufacturer
SS Wholesale Inc. dba Jobbers Wholesale
Category
Drug — Unapproved New Drug
Hazard
Affected units
2,395

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)

  • Lot #: KWAKPMC030505175957019
  • Exp 12/16

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by SS Wholesale Inc. dba Jobbers Wholesale 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 →

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