FDA Recalls Rhino 5 Capsules Containing Unapproved Drug Ingredients

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

• undeclared-drug-ingredients
• unapproved-new-drug

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.

Distribution

Related recalls