1,463 recalls · Class I, newest first
Reason 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.
Reason 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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.
Reason Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Reason Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Reason 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.
Reason 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.
Reason 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.
Reason 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.
Reason Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Reason Non-Sterility
Reason Presence of Particulate Matter; contains visible particulate matter identified as mold.
Reason Subpotent
Reason LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Reason Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Reason Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Reason Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Reason Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Reason 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.
Reason Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Reason 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
Reason Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Reason 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
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.