Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

44 recalls · Class I, newest first

Class I · High risk

BLUE PEARL capsules

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

Terminated Chemical / undeclared Blue Fusion Natural D-0247-2018
Class I · High risk

Hard Times For Men capsules

Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.

Terminated Chemical / undeclared www.blankterrmall.com D-0470-2018
Class I · High risk

grande X 5800 capsule

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Terminated Chemical / undeclared Gadget Island, Inc D-0106-2018
Class I · High risk

FIFTY SHADES 6000 capsule

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Terminated Chemical / undeclared Gadget Island, Inc D-0105-2018
Class I · High risk

PapaZen 3300 capsule

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Terminated Chemical / undeclared Gadget Island, Inc D-0104-2018
Class I · High risk

RHINO 7 Platinum 5000

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Terminated Chemical / undeclared Gadget Island, Inc D-0103-2018
Class I · High risk

Natural Herbal Coffee Ampt

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.

Terminated Chemical / undeclared The Ampt Life, LLC D-0126-2018
Class I · High risk

MAN OF STEEL capsules

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

Terminated Chemical / undeclared Vitility D-0032-2018
Class I · High risk

CaverFlo Natural Herbal Coffee

Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk

Terminated Chemical / undeclared Brian P. Richardson D-1117-2017
Class I · High risk

GEC LX Laxoplex 60 capsules Dietary Supplement

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.

Terminated Chemical / undeclared Genetic Edge Compounds LLC D-1092-2017

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