Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class III · Low risk
Pioglitazone and Metformin Hydrochloride Tablets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class II · Moderate risk
Olmesartan Medoxomil Tablets 20 mg
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Class III · Low risk
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Class III · Low risk
Montelukast Sodium Chewable Tablets
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Class II · Moderate risk
Walgreens Acne Cleansing Bar
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
Class II · Moderate risk
Zinc Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate/Progesterone Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Super MIC Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Selenium Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Pyridoxine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Iohexol
Lack of Assurance of Sterility