Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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 I · High risk
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%
Chemical Contamination: Product contains methanol.
Class II · Moderate risk
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%
CGMP Deviations
Class II · Moderate risk
Vancomycin HCL 1.5 mg Edge Pharma
Labeling: Label Error on Declared Strength
Class II · Moderate risk
Yohimbine HCL 5.4mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Vardenafil 20 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Testosterone/Anastrozole Pellet 100/6 mg
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 7 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 3 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 26 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 18 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 12 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Sildenafil 50 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone Modified Release 200 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone Modified Release 100 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 50 mg Modified Release Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 200 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 300 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 150 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Minoxidil/Biotin 1.25mg/5mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).