Class I · High risk
BLUE Diamond PLATINUM Capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
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
BLUE Diamond Pill
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class I · High risk
libigrow XXXTREME Capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class I · High risk
libigrow capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class I · High risk
WOW, Health Enterprises
Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
Class I · High risk
Ultimate Formula
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Classic Zi Xiu Tang
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Class II · Moderate risk
Lactated Ringer's Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
5% Dextrose and 0.45% Sodium Chloride Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
10% Dextrose Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
5% Dextrose Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class I · High risk
SLIM XTREME Herbal Slimming Capsule
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Class I · High risk
Reumofan Plus Tablets
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Class I · High risk
Mojo Nights for Her
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class I · High risk
Mojo Nights
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Walgreens ASPIRIN FREE TENSION HEADACHE
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Class I · High risk
Z-ROCK All Natural Male Supplement. 1 capsule blister pack
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Class I · High risk
X-ROCK 3 Day Pill For Men
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Class III · Low risk
Erythromycin Topical Solution USP
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Class I · High risk
V Maxx Rx
Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
Class I · High risk
a) Firminite 805 mg is packaged in 2 count
Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.
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