Browse Drug Recalls

538 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 538 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 538 FDA drug recalls.

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DateProductReasonClassFirm
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
Jul 2, 2013 PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, Rx only, Distribute... Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potential... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak ... Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as LIS... Class II Aidapak Services, LLC
Jul 2, 2013 NORTRIPTYLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 50 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 HYDROCHLOROTHIAZIDE Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service... Labeling: Label Mixup; HYDROCHLOROTHIAZIDE Tablet, 12.5 mg may be potentially mislabeled as ch... Class II Aidapak Services, LLC
Jul 2, 2013 NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, ... Class II Aidapak Services, LLC
Jul 2, 2013 lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak ... Labeling: Label Mixup; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), Over The Counter, Dist... Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) may be potentially m... Class II Aidapak Services, LLC
Jul 2, 2013 REPAGLINIDE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of t... Class II Aidapak Services, LLC
Jul 2, 2013 EFAVIRENZ, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the fol... Class II Aidapak Services, LLC
Jul 2, 2013 COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling:Label Mixup; COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIg... 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.