Class I · High risk
RHINO 7 Platinum 5000
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Chemical contamination & hidden ingredients
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines.
709 FDA drug recalls with this cause, newest first.
This category covers two things the label never mentions. One is chemical contamination: benzene in sunscreens and hand sanitizers, methanol in sanitizer, lead or other heavy metals in a finished product. The other is a 'supplement' that secretly contains a prescription drug - sildenafil, tadalafil, sibutramine, phenolphthalein - so that it appears to work, at the cost of dangerous interactions the buyer cannot anticipate. A large share of these recalls are Class I, because the hidden ingredient is the whole risk.
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.
Class I · High risk
LaBri's Body Health XPLODE 30 capsules Exclusively distribute…
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk
LaBri's Body Health Atomic 60 Capsules Exclusively distributed…
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk
Super Panther 7K Capsules 1250 mg blend
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Class I · High risk
New Kopi Jantan Tradisional Natural Herbs Coffee
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Class II · Moderate risk
Timolol-Brimonidine-Dorzolamide-Latanoprost
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Timolol-Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Curcumin Emulsion 10mg/ml Injection
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
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.
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
Class I · High risk
Biotech Underground Tri-Ton Hardcore Formula capsules
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
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.
Class I · High risk
LabidaMAX Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ZRECT for Women Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ENHANCEROL Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
TORNADO Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
RECTALIS Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
Xrect Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ZRECT Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
Cummor Natural Male Enhancement
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
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