Class I · High risk Terminated
Rhino 7 3000
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Rhino 7 Platinum 3000
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Class I · High risk Terminated
Rhino 7 3000
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Class I · High risk Terminated
Ultimate Herbal Slimcap Capsules
Reason Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.
Class I · High risk Terminated
Rhino 7 Platinum 3000
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Class I · High risk Terminated
Rhino 7 3000
Reason Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Class I · High risk Terminated
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class I · High risk Terminated
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class I · High risk Terminated
Shorts on The Beach Golden Edition by Pink Bikini
Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class I · High risk Terminated
Shorts on The Beach Strong Formula by Pink Bikini capsules
Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class I · High risk Terminated
Pink Bikini Strong Formula capsules
Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class I · High risk Ongoing
MIRACLE DIET 30 capsules
Reason Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
Class I · High risk Ongoing
MIRACLE ROCK 48 capsules
Reason Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Class I · High risk Terminated
Xcellerator
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
Thin and Slim Extreme Stack Fat Burner Dietary Supplement…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
Thin and Slim Naturally The Natural Alternative AM Dietary…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
TruTrim
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
Thin and Slim Burn Fat Now Dietary Supplement packaged in 90…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk Terminated
The People's Chemist Thermo FX Barely Legal Thermogenic Aid
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.