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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Date	Product	Reason	Class	Firm
Jul 2, 2013	METHOCARBAMOL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC,...	Labeling: Label Mixup: METHOCARBAMOL, Tablet, 500 mg may have potentially been mislabeled as the ...	Class II	Aidapak Services, LLC
Jul 2, 2013	LEVOTHYROXINE SODIUM, Tablet, 137 mcg, Rx only, Distributed by: AidaPak Servi...	Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled...	Class II	Aidapak Services, LLC
Jul 2, 2013	TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Servi...	Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	NEOMYCIN SULFATE Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LL...	Labeling: Label Mixup; NEOMYCIN SULFATE, Tablet, 500 mg may be potentially mislabeled as IMIPR...	Class II	Aidapak Services, LLC
Jul 2, 2013	LACTOBACILLUS GG Capsule, 10 Billion Cells, Over The Counter, Distributed by:...	Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	DOCUSATE SODIUM Capsule, 100 mg, Over The Counter, Distributed by: AidaPak Se...	Labeling:Label Mixup; DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSAT...	Class II	Aidapak Services, LLC
Jul 2, 2013	SIMVASTATIN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, ND...	Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the fol...	Class II	Aidapak Services, LLC
Jul 2, 2013	NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, ...	Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as ASPI...	Class II	Aidapak Services, LLC
Jul 2, 2013	PREGABALIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of...	Class II	Aidapak Services, LLC
Jul 2, 2013	QUINAPRIL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 3...	Labeling: Label Mixup; QUINAPRIL Tablet, 40 mg may be potentially mislabeled as PROPRANOLOL HC...	Class II	Aidapak Services, LLC
Jul 2, 2013	VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg, Over The Counter, Distribu...	Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg may be potentially misl...	Class II	Aidapak Services, LLC
Jul 2, 2013	MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND...	Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTIN...	Class II	Aidapak Services, LLC
Jul 2, 2013	DESMOPRESSIN ACETATE, Tablet 0.1 mg, Rx only, Distributed by: AidaPak Service...	Labeling: Label Mixup: DESMOPRESSIN ACETATE, Tablet 0.1 mg may have potentially been mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	DISULFIRAM Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC...	Labeling: Label Mixup; DISULFIRAM Tablet, 250 mg may be potentially mislabeled as PYRIDOXINE H...	Class II	Aidapak Services, LLC
Jul 2, 2013	azaTHIOprine, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup: azaTHIOprine, Tablet, 50 mg may have potentially been mislabeled as the fo...	Class II	Aidapak Services, LLC
Jul 2, 2013	TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: Aid...	Labeling: Label Mixup:TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg) may have potentially been m...	Class II	Aidapak Services, LLC
Jul 2, 2013	NICOTINE POLACRILEX Gum, 2 mg, Rx only, Distributed by: AidaPak Service, LLC,...	Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHARO...	Class II	Aidapak Services, LLC
Jul 2, 2013	PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC,...	Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHEN...	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 ...	Class II	Aidapak Services, LLC
Jul 2, 2013	LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Servic...	Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one o...	Class II	Aidapak Services, LLC
Jul 2, 2013	QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service,...	Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULT...	Class II	Aidapak Services, LLC
Jul 2, 2013	LETROZOLE Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ...	Labeling:Label Mixup; LETROZOLE Tablet, 2.5 mg may be potentially mislabeled as METOPROLOL TAR...	Class II	Aidapak Services, LLC
Jul 2, 2013	CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, Over The Cou...	Labeling: Label Mixup: CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg may have p...	Class II	Aidapak Services, LLC
Jul 2, 2013	DOXAZOSIN MESYLATE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak S...	Labeling: Label Mixup: DOXAZOSIN MESYLATE, Tablet, 1 mg may have potentially been mislabeled as t...	Class II	Aidapak Services, LLC
Jul 2, 2013	CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, T...	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 be potentially mislabeled as LAC...	Class II	Aidapak Services, LLC
Jul 2, 2013	CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPa...	Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as A...	Class II	Aidapak Services, LLC
Jul 2, 2013	CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak...	Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CY...	Class II	Aidapak Services, LLC
Jul 2, 2013	PROPRANOLOL HCL Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC,...	Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBAC...	Class II	Aidapak Services, LLC
Jul 2, 2013	MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL...	Class II	Aidapak Services, LLC
Jul 2, 2013	ATORVASTATIN CALCIUM, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service...	Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 20 mg may have potentially been mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Se...	Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabe...	Class II	Aidapak Services, LLC
Jul 2, 2013	LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 00574022001, Rx only, Distributed by:...	Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 5 mcg may have potentially been mislabeled as...	Class II	Aidapak Services, LLC
Jul 2, 2013	GALANTAMINE HBR ER Capsule, 24 mg, Rx only, Distributed by: AidaPak Service, ...	Labeling: Label Mixup; GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESC...	Class II	Aidapak Services, LLC
Jul 2, 2013	PANTOPRAZOLE SODIUM DR Tablet, 40 mg, Rx only, Distributed by: AidaPak Servic...	Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SE...	Class II	Aidapak Services, LLC
Jul 2, 2013	CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, ND...	Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may have potentially been mislabeled as the fol...	Class II	Aidapak Services, LLC
Jul 2, 2013	LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: ...	Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially misl...	Class II	Aidapak Services, LLC
Jul 2, 2013	DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup; DOXEPIN HCL Capsule, 150 mg may be potentially mislabeled as VALSARTAN,...	Class II	Aidapak Services, LLC
Jul 2, 2013	HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distrib...	Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potent...	Class II	Aidapak Services, LLC
Jul 2, 2013	SODIUM CHLORIDE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Serv...	Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1 mg may have potentially been mislabeled as one ...	Class II	Aidapak Services, LLC
Jul 2, 2013	QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,...	Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCU...	Class II	Aidapak Services, LLC
Jul 2, 2013	tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the f...	Class II	Aidapak Services, LLC
Jul 2, 2013	NEFAZODONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC...	Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 150 mg may have potentially been mislabeled as the...	Class II	Aidapak Services, LLC
Jul 2, 2013	DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one o...	Class II	Aidapak Services, LLC
Jul 2, 2013	HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Ser...	Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Servic...	Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled ...	Class II	Aidapak Services, LLC
Jul 2, 2013	ALLOPURINOL Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, ND...	Labeling: Label Mixup; ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCI...	Class II	Aidapak Services, LLC
Jul 2, 2013	LIOTHYRONINE SODIUM, Tablet 25 mcg, Rx only, Distributed by: AidaPak Service,...	Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as gua...	Class II	Aidapak Services, LLC
Jul 2, 2013	BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Se...	Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, L...	Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMI...	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.