Class I · High risk
Clinimix 4.25/25 sulfite-free
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
50 mg Nitroglycerin in 5% Dextrose Injection
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
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
Glycopyrrolate
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
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
Soliris (eculizumab)
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Class I · High risk
Human Chorionic Gonadotropin
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Class I · High risk
Dextrose* Vial In Sterile Water
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Class I · High risk
Cefepime for Injection USP and Dextrose Injection USP
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
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 I · High risk
Virilis Pro
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
PHUK Sexual Enhancement Ultimate Pleasure
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
Prolifta Dietary Supplement Prolifta
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.