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

FDA drug recalls in 2013

Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

2,085 recalls, 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

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
Class II · Moderate risk

COLCHICINE Tablet

Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904

Terminated Labeling / mix-up Aidapak Services, LLC D-696-2014
Class II · Moderate risk

HYDROCORTISONE Tablet

Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-695-2014
Class II · Moderate risk

METAXALONE Tablet

Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-694-2014
Class II · Moderate risk

ZONISAMIDE Capsule

Labeling: Label Mixup; ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003737, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-693-2014
Class II · Moderate risk

LISINOPRIL Tablet

Labeling: Label Mixup; LISINOPRIL Tablet, 2.5 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD23087_1, EXP: 5/2/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: W003358, EXP: 6/19/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-692-2014
Class II · Moderate risk

Zolpidem Tartrate

Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD22861_7, EXP: 5/8/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-691-2014
Class II · Moderate risk

PANTOPRAZOLE SODIUM DR Tablet

Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree: AD37063_17, EXP: 5/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-690-2014
Class II · Moderate risk

PANTOPRAZOLE SODIUM DR Tablet

Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-689-2014
Class II · Moderate risk

MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet

Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00527134601, Pedigree: AD60272_22, EXP: 5/22/2014; ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: AD73627_1, EXP: 5/30/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: W002513, EXP: 6/3/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-688-2014
Class II · Moderate risk

Multivitamin/Multimineral W/Fluoride

Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) may be potentially mislabeled as ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: AD22858_1, EXP: 3/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-687-2014
Class II · Moderate risk

Benzocaine/Menthol

Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: AD32345_1, EXP: 5/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-686-2014
Class II · Moderate risk

BENZOCAINE/MENTHOL Lozenge

Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-685-2014
Class II · Moderate risk

guaiFENesin ER Tablet

Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-684-2014
Class II · Moderate risk

guaiFENesin ER Tablet

Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014; DOCUSATE SODIUM, Capsule, 250 mg,

Terminated Labeling / mix-up Aidapak Services, LLC D-683-2014
Class II · Moderate risk

guaiFENesin ER

Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216

Terminated Labeling / mix-up Aidapak Services, LLC D-682-2014
Class II · Moderate risk

Lurasidone HCL

Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486, EXP: 6/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-681-2014
Class II · Moderate risk

Eszopiclone

Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-680-2014

Recalls by year