17,898 recalls, newest first
Reason Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Reason Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs