Class III · Low risk
Salicylic Acid Shampoo
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class II · Moderate risk
Kojic Acid 8%/Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Intimate Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Gentle Supreme Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Custom Lightening/Brightening Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Sulfur 5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Sulfacetamide 10%/Hydrocortisone 1% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Hydrocortisone 2.5% With Aloe Vera Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Metronidazole 1% Gel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
LIDOCAINE CREAM in all strengths including: 5%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Retin-A 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Purified Water
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Melatonin 1.5mg Spray
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tretinoin 0.02% in Oil Free Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
TRETINOIN CREAM in all strengths including: 0.1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Hydroquinone 28% Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HYDROQUINONE CREAM in all strengths including: 4%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HCG in all strength including: 2
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Enhanced Retin Anti-Wrinkle Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Enhanced Retin Anti-Wrinkle Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Betamethasone 0.25%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.