Class III · Low risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class III · Low risk
PF-Succinylcholine Chloride Injection
Incorrect labeling: Incorrect or missing lot and/or exp date
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Cinnamon
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Natural Flavor
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Wintergreen
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 2400
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz.
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Nuovi Firming Masque
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset Nuovi Skin Toner
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Miracle Facelift Masque
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset Earth Wash Cleaner and Personal Care
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
Class II · Moderate risk
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx…
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx…
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension
Labeling: Incorrect or missing package insert.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Isotretinoin Capsules
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class II · Moderate risk
Viatrexx-ANS/CNS
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Male+
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Neuro
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Hair
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk
Viatrexx-Facial
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.