Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
cGMP Deviations
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
CGMP deviations: Product bottle may be absent of desiccant.
CGMP deviations: Product bottle may be absent of desiccant.
GMP Deviations: Product bottle may be absent of desiccant.
GMP Deviations: Product bottle may be absent of desiccant.
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility