Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Cinacalcet Tablets 30 mg
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Liceout
Reason CGMP violations.
Class II · Moderate risk Ongoing
Liceout
Reason CGMP violations.
Class II · Moderate risk Ongoing
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Class III · Low risk Ongoing
Ciclopirox Gel 0.77%
Reason Defective Container: Firm received complaints of broken tube at the seal.
Class III · Low risk Ongoing
Kids' Cough and Chest Congestion
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk Ongoing
Adult Cough and Chest Congestion
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Ongoing
Ryaltris
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk Ongoing
Pluvicto
Reason CGMP deviations
Class II · Moderate risk Ongoing
EnviroClean Hand Sanitizer Gel
Reason CGMP deviations
Class I · High risk Ongoing
Vail-Bon Jie Yang Wan capsules
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Class II · Moderate risk Ongoing
Refresh LACRI-LUBE
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk Ongoing
Refresh P.M.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk Ongoing
First Aid Antiseptic Ointment
Reason Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Class II · Moderate risk Ongoing
Mycophenolic Acid Delayed-Release Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Vivier Sheer SPF 30 Mineral With Antioxidants
Reason Microbial Contamination of Non-Sterile Product
Class II · Moderate risk Ongoing
Barrier Therapy Skin Protectant Cream
Reason Microbial contamination of non-sterile Products -
Class III · Low risk Ongoing
AcetaZOLAMIDE Tablets
Reason Discoloration
Class II · Moderate risk Ongoing
TIRZEPATIDE 60 mg/3mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TIRZEPATIDE 20 mg/2mL
Reason Lack of Assurance of Sterility