Class III · Low risk
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Famciclovir tablets
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
PreviDent 5000 ppm
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Class III · Low risk
Salicylic Acid Cream
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
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.
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.