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).
FDA Drug Recalls
526 recalls, newest first
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Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.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.
Class I · High risk
X-ROCK For Men
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Class I · High risk
Japan Weight Loss Blue Capsules
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Class I · High risk
Man King Capsules
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Class I · High risk
Hard Ten Days Capsule
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Class II · Moderate risk
Lipitor (Atorvastatin calcium)
Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Class I · High risk
Actra-SX 500 Capsules
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Class III · Low risk
Earth Force
Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).