1,739 recalls · Class I, newest first
Reason Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg…
Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg…
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Reason Presence of Particulate Matter.
Reason Presence of Particulate Matter.
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: Product found to be tainted with Tadalafil.
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Reason Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Reason Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Reason Failed dissolution specifications : failed results at the 3-month stability time point.
Reason Presence of Particulate Matter; glass particulates
Reason Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is…
Reason Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The…
Reason Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection…
Reason Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection…
Reason Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Reason Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Reason Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product