Class II · Moderate risk Terminated
Auryxia
Reason cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Shine & Clean Hand Sanitizer gel
Reason CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vancomycin HCL 1.5 mg Edge Pharma
Reason Labeling: Label Error on Declared Strength
Class II · Moderate risk Terminated
Yohimbine HCL 5.4mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Vardenafil 20 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Testosterone/Anastrozole Pellet 100/6 mg
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 7 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 3 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 26 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 18 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 12 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Sildenafil 50 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone Modified Release 200 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone Modified Release 100 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone 50 mg Modified Release Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone 200 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone 300 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone 150 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).