US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
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.

Maquiladora Miniara Sa De Cv NDC 76753-001-01 D-1565-2020
Class II · Moderate risk Ongoing

Metformin Hydrochloride Extended-Release Tablets USP

Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Granules Pharmaceuticals Inc NDC 70010-492-01 D-1386-2020
Class II · Moderate risk Terminated

Vancomycin HCL 1.5 mg Edge Pharma

Reason Labeling: Label Error on Declared Strength

Edge Pharma, LLC NDC 05446-1458-01 D-1562-2020
Class II · Moderate risk Terminated

Yohimbine HCL 5.4mg Capsule

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1443-2020
Class II · Moderate risk Terminated

Vardenafil 20 mg Troche

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1442-2020
Class II · Moderate risk Terminated

Testosterone/Anastrozole Pellet 100/6 mg

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1441-2020
Class II · Moderate risk Terminated

Tadalafil 7 mg Capsule

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1440-2020
Class II · Moderate risk Terminated

Tadalafil 3 mg Capsule

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1439-2020
Class II · Moderate risk Terminated

Tadalafil 26 mg Capsule

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1438-2020
Class II · Moderate risk Terminated

Tadalafil 18 mg Capsule

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1437-2020
Class II · Moderate risk Terminated

Tadalafil 12 mg Capsule

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1436-2020
Class II · Moderate risk Terminated

Sildenafil 50 mg Troche

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1435-2020
Class II · Moderate risk Terminated

Progesterone 200 mg Troche

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1431-2020
Class II · Moderate risk Terminated

Progesterone

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1430-2020
Class II · Moderate risk Terminated

Progesterone 300 mg Troche

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1429-2020
Class II · Moderate risk Terminated

Progesterone 150 mg Troche

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1428-2020
Class II · Moderate risk Terminated

Progesterone

Reason Lack of Processing Controls (lack of assurance of conformity to specifications).

MasterPharm LLC D-1427-2020