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Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,002 FDA drug recalls.

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DateProductReasonClassFirm
Jul 2, 2013 RIBAVIRIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, T... Class II Aidapak Services, LLC
Jul 2, 2013 VENLAFAXINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 25 mg may have potentially been mislabeled as one... Class II Aidapak Services, LLC
Jul 2, 2013 FLUVASTATIN, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the fo... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Dist... Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) may be potentially m... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of t... Class II Aidapak Services, LLC
Jul 2, 2013 SOTALOL HCL, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the fo... Class II Aidapak Services, LLC
Jul 2, 2013 SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTY... Class II Aidapak Services, LLC
Jul 2, 2013 BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Serv... Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabele... Class II Aidapak Services, LLC
Jul 2, 2013 guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL... Class II Aidapak Services, LLC
Jul 2, 2013 COENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Serv... Labeling: Label Mixup; COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELI... Class II Aidapak Services, LLC
Jul 2, 2013 CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, ... Class II Aidapak Services, LLC
Jul 2, 2013 PRAMIPEXOLE DI-HCL Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPRO... Class II Aidapak Services, LLC
Jul 2, 2013 PYRIDOXINE HCL, Tablet, 25 mg, Over The Counter, Distributed by: AidaPak Serv... Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 25 mg may have potentially been mislabeled as the ... Class II Aidapak Services, LLC
Jul 2, 2013 PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of... Class II Aidapak Services, LLC
Jul 2, 2013 QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: ... Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially misl... Class II Aidapak Services, LLC
Jul 2, 2013 DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROP... Class II Aidapak Services, LLC
Jul 2, 2013 METOPROLOL TARTRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 25 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 ASCORBIC ACID Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Servi... Labeling:Label Mixup; ASCORBIC ACID Tablet, 500 mg may be potentially mislabeled as FEBUXOSTAT... Class II Aidapak Services, LLC
Jul 2, 2013 BENAZEPRIL HCL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE... Class II Aidapak Services, LLC
Jul 2, 2013 METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: ... Labeling:Label Mixup; METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially misla... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter,... Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentia... Class II Aidapak Services, LLC
Jul 2, 2013 ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPI... Class II Aidapak Services, LLC
Jul 2, 2013 SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPa... Labeling: Label Mixup: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg may have potentially been mis... Class II Aidapak Services, LLC
Jul 2, 2013 PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by:... Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 chlordiazePOXIDE HCl, Capsule, 25 mg, Rx only, Distributed by: AidaPak Servic... Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled ... Class II Aidapak Services, LLC
Jul 2, 2013 SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B CO... Class II Aidapak Services, LLC
Jul 2, 2013 traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHAS... Class II Aidapak Services, LLC
Jul 2, 2013 quiNIDine SULFATE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup:quiNIDine SULFATE, Tablet, 200 mg may have potentially been mislabeled as t... Class II Aidapak Services, LLC
Jul 2, 2013 PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup; PARoxetine HCl, Tablet, 10 mg may be potentially mislabeled as PANTOPRA... Class II Aidapak Services, LLC
Jul 2, 2013 PARICALCITOL, Capsule, 1 mcg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one o... Class II Aidapak Services, LLC
Jul 2, 2013 THYROID, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00... Labeling: Label Mixup: THYROID, Tablet, 60 mg may have potentially been mislabeled as the followi... Class II Aidapak Services, LLC
Jul 2, 2013 BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Serv... Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabele... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 6... Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as PRENAT... Class II Aidapak Services, LLC
Jul 2, 2013 OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE... Class II Aidapak Services, LLC
Jul 2, 2013 RASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service... Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OME... Class II Aidapak Services, LLC
Jul 2, 2013 DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BI... Class II Aidapak Services, LLC
Jul 2, 2013 VERAPAMIL HCL, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: VERAPAMIL HCL, Tablet, 40 mg may have potentially been mislabeled as one o... Class II Aidapak Services, LLC
Jul 2, 2013 TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Serv... Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as on... Class II Aidapak Services, LLC
Jul 2, 2013 FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE,... Class II Aidapak Services, LLC
Jul 2, 2013 GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distrib... Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially misl... Class II Aidapak Services, LLC
Jul 2, 2013 LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0... Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the follow... Class II Aidapak Services, LLC
Jul 2, 2013 SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling:Label Mixup; SELEGILINE HCL, Capsule, 5 mg may be potentially mislabeled as ITRACONAZ... Class II Aidapak Services, LLC
Jul 2, 2013 MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium), Ove... Labeling:Label Mixup; MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium) ma... Class II Aidapak Services, LLC
Jul 2, 2013 THIOTHIXENE, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: THIOTHIXENE, Capsule, 1 mg may have potentially been mislabeled as the fol... Class II Aidapak Services, LLC
Jul 2, 2013 ASPIRIN DR EC, Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Servi... Labeling: Label Mixup: ASPIRIN DR EC, Tablet, 81 mg may have potentially been mislabeled as one o... Class II Aidapak Services, LLC
Jul 2, 2013 CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 1000 mcg may have potentially been mislabeled as o... Class II Aidapak Services, LLC
Jul 2, 2013 ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 5... Labeling: Label Mixup; ETODOLAC, Tablet, 400 mg may be potentially mislabeled as PANCRELIPASE ... Class II Aidapak Services, LLC
Jul 2, 2013 PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by:... Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak S... Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 PANCRELIPASE DR Capsule, Rx only, Distributed by: AidaPak Service, LLC, NDC 4... Labeling: Label Mixup; PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tab... Class II Aidapak Services, LLC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.