Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

1,803 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2013 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Metoprolol Tartrate

Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, Pedigree: W003843, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 60505257909, Pedigree: W003846, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: W003898, EXP: 6/27/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-825-2014
Class II · Moderate risk

Diltiazem HCL

Labeling: Label Mixup: DILTIAZEM HCL, Tablet, 120 mg, may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: AD329737, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-824-2014
Class II · Moderate risk

Carbidopa/Levodopa

Labeling: Label Mixup: CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD46426_22, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-823-2014
Class II · Moderate risk

Venlafaxine HCL

Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 25 mg may have potentially been mislabeled as one of the following drugs: sitaGLIPtin PHOSPHATE, Tablet, 50 mg, NDC 00006011231, Pedigree: W002824, EXP: 6/7/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: W003847, EXP: 6/27/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD62796_1, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-822-2014
Class II · Moderate risk

Desloratadine

Labeling: Label Mixup: DESLORATADINE, Tablet, 5 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30180_28, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-821-2014
Class II · Moderate risk

carBAMazepine ER

Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ISOSORBIDE DINITRATE ER, Tablet, 40 mg, NDC 57664060088, Pedigree: AD23082_4, EXP: 5/3/2014; SIROLIMUS, Tablet, 1 mg, NDC 00008104105, Pedigree: W003329, EXP: 6/18/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-820-2014
Class II · Moderate risk

Valsartan

Labeling: Label Mixup: VALSARTAN, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD52372_4, EXP: 5/17/2014; ZINC SULFATE, Capsule, 50 mg, NDC 00904533260, Pedigree: AD30994_8, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-819-2014
Class II · Moderate risk

Mycophenolic Acid Dr

Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-818-2014
Class II · Moderate risk

Valsartan

Labeling: Label Mixup: VALSARTAN, Tablet, 320 mg may have potentially been mislabeled as the following drug: CILOSTAZOL, Tablet, 100 mg, NDC 60505252201, Pedigree: AD65475_4, EXP: 5/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-817-2014
Class II · Moderate risk

Valsartan

Labeling: Label Mixup: VALSARTAN, Tablet, 160 mg may have potentially been mislabeled as one of the following drugs: PROGESTERONE, Capsule, 100 mg, NDC 00032170801, Pedigree: AD46320_1, EXP: 5/15/2014; CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), NDC 00143117101, Pedigree: AD46312_4, EXP: 5/16/2014; MYCOPHENOLATE MOFETIL, Tablet, 500 mg, NDC 00004026001, Pedigree: AD49414_4, EXP: 5/17/2014;

Terminated Labeling / mix-up Aidapak Services, LLC D-816-2014
Class II · Moderate risk

Valsartan

Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD49418_1, EXP: 5/17/2014; VALSARTAN, Tablet, 320 mg, NDC 00078036034, Pedigree: AD65475_7, EXP: 5/28/2014; ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD67989_10, EXP: 5/28/2014; CHOLECALCIFEROL, Tablet

Terminated Labeling / mix-up Aidapak Services, LLC D-815-2014
Class II · Moderate risk

Fluvastatin Sodium

Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD73597_1, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-814-2014
Class II · Moderate risk

Riluzole

Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62986_10, EXP: 5/23/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-813-2014
Class II · Moderate risk

Levothyroxine Sodium

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00536406001, Pedigree: AD22865_13, EXP: 5/2/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-812-2014
Class II · Moderate risk

Levothyroxine Sodium

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-811-2014
Class II · Moderate risk

Levothyroxine Sodium

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 125 mcg may have potentially been mislabeled as the following drug: MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD70615_1, EXP: 2/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-810-2014
Class II · Moderate risk

Paricalcitol

Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 500 mg, NDC 60258014101, Pedigree: AD23082_19, EXP: 5/6/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W002666, EXP: 6/5/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-809-2014
Class II · Moderate risk

Niacin ER

Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000 units, NDC 53191036201, Pedigree: AD60268_4, EXP: 5/22/2014; METAXALONE, Tablet, 800 mg, NDC 64720032110, Pedigree: W003738, EXP: 6/26/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003716, EXP: 6/26/2014; C

Terminated Labeling / mix-up Aidapak Services, LLC D-808-2014
Class II · Moderate risk

Phenytoin Sodium ER

Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W003327, EXP: 6/19/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-807-2014
Class II · Moderate risk

Pregabalin

Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00781570192, Pedigree: AD21965_10, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD30180_25, EXP: 5/9/2014; clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00093083201, Pedigree: AD73518_1, EXP: 5/31/2014; OM

Terminated Labeling / mix-up Aidapak Services, LLC D-806-2014
Class II · Moderate risk

Pregabalin

Labeling: Label Mixup: PREGABALIN, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003713, EXP: 6/26/2014; glyBURIDE MICRONIZED, Tablet, 3 mg, NDC 00093803501, Pedigree: W003155, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-805-2014
Class II · Moderate risk

Sildenafil Citrate

Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, NDC 66213042510, Pedigree: W003640, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-804-2014
Class II · Moderate risk

Varenicline

Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-803-2014
Class II · Moderate risk

Phenol

Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-802-2014
Class II · Moderate risk

Efavirenz

Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: AD73637_1, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-801-2014

Recalls by year