Class I · High risk
Red Zone Xtreme 3000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
Bella Capsules
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk
Limbrel500
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel250
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel (flavocoxid 500 mg)
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel (flavocoxid 250 mg)
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Senna Laxative
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Class I · High risk
Hcg 5
Non-Sterility
Class I · High risk
Levofloxacin in 5% Dextrose Injection
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Class I · High risk
Class I · High risk
Clopidogrel Tablets
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Class I · High risk
Ampicillin and Sulbactam for Injection 1.5 g vial
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Class I · High risk
Linezolid Injection 600 mg/300 mL
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Class I · High risk
BodySlim Herbal Advanced technology & Strong formula capsules
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Class I · High risk
Pantoprazole Sodium for Injection
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Class I · High risk
BLUE PEARL 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
Hard Times For Men capsules
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class I · High risk
Nexterone (amiodarone HCl)
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Class I · High risk
GERICARE Eyewash
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Class I · High risk
Midazolam Injection
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Class I · High risk
diphenoxylate hydrochloride and atropine sulfate tablets
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class I · High risk
Enhanced Vegetal Vigra 200 mg Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Class I · High risk
grande X 5800 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.