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Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
Jul 2, 2013 ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Count... Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be poten... Class II Aidapak Services, LLC
Jul 2, 2013 VENLAFAXINE HCL, Tablet, 75 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 75 mg may have potentially been mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 LOSARTAN POTASSIUM, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 MYCOPHENOLATE MOFETIL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Servi... Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as th... Class II Aidapak Services, LLC
Jul 2, 2013 PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Serv... Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one ... Class II Aidapak Services, LLC
Jul 2, 2013 FLUVASTATIN SODIUM, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 ERYTHROMYCIN DR EC Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup; ERYTHROMYCIN DR EC Tablet, 250 mg may be potentially mislabeled as meth... Class II Aidapak Services, LLC
Jul 2, 2013 ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one... Class II Aidapak Services, LLC
Jul 2, 2013 buPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Servi... Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as M... Class II Aidapak Services, LLC
Jul 2, 2013 ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service... Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFA... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, Over The Counter, Distribu... Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium may be potentially misla... Class II Aidapak Services, LLC
Jul 2, 2013 MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg), Over The Counter, Distrib... Labeling: Label Mixup; MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) may be potentially misl... Class II Aidapak Services, LLC
Jul 2, 2013 METAXALONE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED E... Class II Aidapak Services, LLC
Jul 2, 2013 FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter, Dis... Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially ... Class II Aidapak Services, LLC
Jul 2, 2013 traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE ... Class II Aidapak Services, LLC
Jul 2, 2013 NIACIN, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the ... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, Over The Counter, Distributed by: Ai... Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg may have potentially been mislabel... Class II Aidapak Services, LLC
Jul 2, 2013 VITAMIN B COMPLEX PROLONGED RELEASE Tablet, Over The Counter, Distributed by:... Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE Tablet may be potentially mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, ... Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMP... Class II Aidapak Services, LLC
Jul 2, 2013 FAMCICLOVIR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: FAMCICLOVIR, Tablet, 500 mg may have potentially been mislabeled as one of... Class II Aidapak Services, LLC
Jul 2, 2013 OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPa... Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PY... Class II Aidapak Services, LLC
Jul 2, 2013 MODAFINIL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup: MODAFINIL, Tablet, 200 mg may have potentially been mislabeled as one of t... Class II Aidapak Services, LLC
Jul 2, 2013 RILUZOLE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64... Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, ... Class II Aidapak Services, LLC
Jul 2, 2013 MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM... Class II Aidapak Services, LLC
Jul 2, 2013 ISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service... Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 PIMOZIDE Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service... Labeling:Label Mixup; PIMOZIDE Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as MET... Class II Aidapak Services, LLC
Jul 2, 2013 NORTRIPTYLINE HCL, Capsule, 75 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 75 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS Tablet, Over The Counter, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULT... Class II Aidapak Services, LLC
Jul 2, 2013 RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN,... Class II Aidapak Services, LLC
Jul 2, 2013 GABAPENTIN, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: GABAPENTIN, Tablet, 600 mg may have potentially been mislabeled as the fol... Class II Aidapak Services, LLC
Jul 2, 2013 ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Count... Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be poten... Class II Aidapak Services, LLC
Jul 2, 2013 DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg, Rx only, Distributed by: AidaPak Ser... Labeling: Label Mixup: DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg may have potentially been mislabel... Class II Aidapak Services, LLC
Jul 2, 2013 MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: Aid... Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabele... Class II Aidapak Services, LLC
Jul 2, 2013 ISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 CHOLECALCIFEROL, Capsule, 2000 units, Over The Counter, Distributed by: AidaP... Labeling: Label Mixup: CHOLECALCIFEROL, Capsule, 2000 units may have potentially been mislabeled ... Class II Aidapak Services, LLC
Jul 2, 2013 aMILoride HCl Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL... Class II Aidapak Services, LLC
Jul 2, 2013 CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, Rx only, Distributed by: AidaPak Ser... Labeling: Label Mixup: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg may be potentially mislabeled as t... Class II Aidapak Services, LLC
Jul 2, 2013 PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Servic... Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as M... Class II Aidapak Services, LLC
Jul 2, 2013 methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, L... Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as o... Class II Aidapak Services, LLC
Jul 2, 2013 TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 3... Labeling: Label Mixup; TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL... Class II Aidapak Services, LLC
Jul 2, 2013 MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL... Class II Aidapak Services, LLC
Jul 2, 2013 GLIMEPIRIDE Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling:Label Mixup; GLIMEPIRIDE, Tablet, 1 mg may be potentially mislabeled as clomiPRAMINE ... Class II Aidapak Services, LLC
Jul 2, 2013 chlorproMAZINE HCl, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 50 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 COLCHICINE Tablet, 0.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFE... Class II Aidapak Services, LLC
Jul 2, 2013 IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SUL... Class II Aidapak Services, LLC
Jul 2, 2013 HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak S... Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaP... Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DO... 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.