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

452 recalls · Class I, newest first

Class I · High risk

LEOPARD Miracle Honey packaged in a wooden box

Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Terminated Chemical / undeclared USA LESS Inc. D-1135-2019
Class I · High risk

7K capsules packaged in single packs sold in 24-count boxes

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Terminated Chemical / undeclared Shoreside Enterprises Inc. D-0880-2018
Class I · High risk

POSEIDON Xtreme PLATINUM 4500

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Terminated Chemical / undeclared Shoreside Enterprises Inc. D-0879-2018
Class I · High risk

Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Terminated Chemical / undeclared AMA Wholesale D-0821-2018
Class I · High risk

Red Zone Xtreme 3000 Capsules

Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

Terminated Chemical / undeclared Jimmy Weber D-0625-2018
Class I · High risk

Bella Capsules

Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.

Terminated Chemical / undeclared Bella All Natural D-0593-2018
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

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