Class I · High risk
Burn 7 Capsules
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
FDA Drug Recalls
86 recalls, newest first
Class I · High risk
Dream Body Slimming Capsule
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Class I · High risk
Magic Slim capsules
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Class I · High risk
Dr. Ming's Chinese Capsule
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Class I · High risk
vitaliKOR Ready When You Are
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Class I · High risk
NATURECT Capsules Dietary Supplement 500 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Class I · High risk
P-BOOST Capsules Dietary Supplement 500 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Class I · High risk
RezzRX capsules
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Class I · High risk
eXtenZone capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b
Class I · High risk
MaXtremeZEN capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved
Class I · High risk
Rhino 5 capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by
Class I · High risk
Adipotrim XT
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Class I · High risk
Hydravax High Potency Diuretic Weight Loss Solution
Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug
Class I · High risk
Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I · High risk
Bella Vi INSANE AMP'D Dietary Supplement capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I · High risk
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I · High risk
Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I · High risk
Bella Vi BTrim MAX Dietary Supplement capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I · High risk
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I · High risk
Slim Expert softgel capsules Dietary Supplement. One month…
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class I · High risk
Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class I · High risk
Slim Fortune capsules Dietary Supplement. Each bottle contains 30…
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class II · Moderate risk
Vicks NyQuil Cold and Flu Nighttime Relief
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
Class I · High risk
PRO POWER MAX Natural Energy Enhancer
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Class I · High risk
72hp Maximum Potency Male Sexual Enhancement
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil