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…
Reason Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled…
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…
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…
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…
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…
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…
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…
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…
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…
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.