Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 recalls, newest first.

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

NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule

Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as MINOCYCLINE HCL, Capsule, 50 mg, NDC 00591569401, Pedigree: AD52778_46, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-577-2014
Class II · Moderate risk

MELATONIN Tablet

Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: AD46265_28, EXP: 5/15/2014; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, NDC 00904559293, Pedigree: AD60211_17, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-576-2014
Class II · Moderate risk

QUETIAPINE FUMARATE Tablet

Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN, Tablet, 40 mg, NDC 00093715598, Pedigree: AD22845_4, EXP: 5/2/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-575-2014
Class II · Moderate risk

GALANTAMINE HBR ER Capsule

Labeling: Label Mixup; GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESCITALOPRAM, Tablet, 5 mg, NDC 00093585001, Pedigree: W003733, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-574-2014
Class II · Moderate risk

buPROPion HCl ER Tablet

Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-573-2014
Class II · Moderate risk

Acetaminophen/ Aspirin/ Caffeine

Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: W003714, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-572-2014
Class II · Moderate risk

DESIPRAMINE HCL Tablet

Labeling: Label Mixup; DESIPRAMINE HCL Tablet, 50 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD30140_4, EXP: 5/7/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-571-2014
Class II · Moderate risk

LORATADINE Tablet

Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-570-2014
Class II · Moderate risk

guaiFENesin ER Tablet

Labeling: Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD21790_52, EXP: 5/1/2014; FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: W002733, EXP: 6/6/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: W003688, EXP: 5/31/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD30140_34, E

Terminated Labeling / mix-up Aidapak Services, LLC D-569-2014
Class II · Moderate risk

FEXOFENADINE HCl Tablet

Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-568-2014
Class II · Moderate risk

ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule

Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially mislabeled as ALBUTEROL SULFATE ER, Tablet, 4 mg, NDC 00378412201, Pedigree: W003578, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD22616_7, EXP: 5/2/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-567-2014
Class II · Moderate risk

ORPHENADRINE CITRATE ER Tablet

Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-566-2014
Class II · Moderate risk

NIFEDIPINE Capsule

Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013.

Terminated Labeling / mix-up Aidapak Services, LLC D-565-2014
Class II · Moderate risk

MISOPROSTOL Tablet

Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP: 5/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-564-2014
Class II · Moderate risk

METHYLERGONOVINE MALEATE Tablet

Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-563-2014
Class II · Moderate risk

LACTOBACILLUS ACIDOPHILUS Capsule

Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002694, EXP: 6/5/2014

Terminated Labeling / mix-up Aidapak Services, LLC D-562-2014
Class II · Moderate risk

Vitamin B Complex

Labeling: Label Mixup; VITAMIN B COMPLEX Tablet may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003789, EXP: 6/27/2014; prednisoLONE, Tablet, 5 mg, NDC 16477050501, Pedigree: W003627, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-561-2014
Class II · Moderate risk

LACTOBACILLUS ACIDOPHILUS Capsule

Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD46257_56, EXP: 5/15/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD30028_28, EXP: 5/7/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD60240_11, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-560-2014
Class II · Moderate risk

Hyoscyamine Sulfate ER

Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-559-2014
Class II · Moderate risk

PANCRELIPASE DR Capsule

Labeling: Label Mixup; PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W003317, EXP: 6/18/2014; VERAPAMIL HCL, Tablet, 40 mg, NDC 00591040401, Pedigree: W003170, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-558-2014
Class II · Moderate risk

Liothyronine Sodium

Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46414_22, EXP: 5/16/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD68010_4, EXP: 5/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-557-2014
Class II · Moderate risk

Liothyronine Sodium

Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 5 mcg may be potentially mislabeled as HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 16729018201, Pedigree: AD46414_25, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-556-2014
Class II · Moderate risk

LEVOTHYROXINE/ LIOTHYRONINE Tablet

Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-555-2014
Class II · Moderate risk

Fexofenadine HCL

Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: AD62992_8, EXP: 5/23/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-554-2014
Class II · Moderate risk

OMEGA-3 FATTY ACID Capsule

Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014; CHOLECALCIFEROL, Capsule, 2000 units, ND

Terminated Labeling / mix-up Aidapak Services, LLC D-553-2014

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