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

Docusate Sodium

Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-721-2014
Class II · Moderate risk

Selegiline HCL

Labeling:Label Mixup; SELEGILINE HCL, Capsule, 5 mg may be potentially mislabeled as ITRACONAZOLE, Capsule, 100 mg, NDC 10147170003, Pedigree: AD54549_10, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-720-2014
Class II · Moderate risk

carBAMazepine ER

Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-719-2014
Class II · Moderate risk

PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE

Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-718-2014
Class II · Moderate risk

Irbesartan

Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP: 6/24/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD76686_7, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-717-2014
Class II · Moderate risk

QUEtiapine FUMARATE

Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD49426_1, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-716-2014
Class II · Moderate risk

rifAXIMin Tablet

Labeling:Label Mixup; rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 25 mg, NDC 00143117201, Pedigree: AD52778_19, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-715-2014
Class II · Moderate risk

COLESEVELAM HCL Tablet

Labeling:Label Mixup; COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIgine Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: AD46265_31, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-714-2014
Class II · Moderate risk

BENAZEPRIL HCL Tablet

Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE HCL, Tablet, 200 mg, NDC 00093102506, Pedigree: AD46414_44, EXP: 5/16/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003931, EXP: 6/28/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD42592_1, EXP: 5/14/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/25

Terminated Labeling / mix-up Aidapak Services, LLC D-713-2014
Class II · Moderate risk

BENAZEPRIL HCL Tablet

Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: AD52993_34, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-712-2014
Class II · Moderate risk

guanFACINE HCl Tablet

Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP: 5/1/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002997, EXP: 6/11/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: W003677, EXP: 2/28/2014; ACYCLOVIR, Capsule, 200 mg, NDC 00093894001, Pedigree: AD60

Terminated Labeling / mix-up Aidapak Services, LLC D-711-2014
Class II · Moderate risk

MULTIVITAMIN/MULTIMINERAL Tablet

Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD62865_13, EXP: 5/23/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003514, EXP: 6/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-710-2014
Class II · Moderate risk

MULTIVITAMIN/MULTIMINERAL Tablet

Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as PRENATAL MULTIVITAMIN/MULTIMINERAL Tablet, NDC 00904531360, Pedigree: AD73652_16, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-709-2014
Class II · Moderate risk

FLECAINIDE ACETATE Tablet

Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-708-2014
Class II · Moderate risk

Promethazine HCL

Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574, EXP: 6/3/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-707-2014
Class II · Moderate risk

Folic Acid

Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD32328_5, EXP: 5/9/2014; DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W003821, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: W003096, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-706-2014
Class II · Moderate risk

RILUZOLE Tablet

Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-705-2014
Class II · Moderate risk

SODIUM BICARBONATE Tablet

Labeling: Label Mixup; SODIUM BICARBONATE Tablet, 650 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: W002974, EXP: 6/11/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-704-2014
Class II · Moderate risk

DISULFIRAM Tablet

Labeling: Label Mixup; DISULFIRAM Tablet, 250 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_22, EXP: 5/2/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-703-2014
Class II · Moderate risk

aMILoride HCl Tablet

Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_37, EXP: 5/22/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003764, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-702-2014
Class II · Moderate risk

CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet

Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL, Tablet, 25 mg, NDC 65162052110, Pedigree: W002578, EXP: 6/3/2014; VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD32579_1, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-701-2014
Class II · Moderate risk

LACTOBACILLUS Tablet

Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62986_1, EXP: 5/23/2014; LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD21790_25, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 100

Terminated Labeling / mix-up Aidapak Services, LLC D-700-2014
Class II · Moderate risk

PHOSPHORUS Tablet

Labeling: Label Mixup; PHOSPHORUS Tablet, 250 mg may be potentially mislabeled as CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: AD56921_1, EXP: 5/21/2014; VENLAFAXINE HCL, Tablet, 75 mg, NDC 00093738201, Pedigree: W002533, EXP: 2/28/2014; NITROFURANTOIN MACROCRYSTALS, Capsule, 50 mg, NDC 47781030701, Pedigree: AD25452_4, EXP: 5/3/2014; traZODone HCl, Tablet, 50 mg, NDC 50111043303, P

Terminated Labeling / mix-up Aidapak Services, LLC D-699-2014
Class II · Moderate risk

FEBUXOSTAT Tablet

Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 59746000103, Pedigree: AD21811_17, EXP: 5/1/2014; tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: W002663, EXP: 6/5/2014; SODIUM CHLORIDE, Tablet, 1000 mg, NDC 00527111610, Pedigree: W003926, EXP: 7/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-698-2014
Class II · Moderate risk

LUBIPROSTONE Capsule

Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-697-2014

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