Class II · Moderate risk
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln
Lack of Assurance of Sterility
FDA drug recalls in 2020
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.
Class II · Moderate risk
Testosterone Cypionate In Sesame Oil 200mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility
Class II · Moderate risk
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml)
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Soln. 1000 mcg/ml
Lack of Assurance of Sterility
Class III · Low risk
Fentanyl Citrate Injection
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Thyro-H
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
BioMycin
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Worm Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Voice Rescue
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Vitiligo Off Ointment
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Vigo-XXX
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Vertigo Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Tution 130
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Thyro-Lo
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Sweat Oil
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Sugar Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Stomach Cleanser
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Sperm Booster
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Skin Moist
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Skin Lift Balm
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Skin Lift
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs