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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 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
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 OMEGA-3-A... Class II Aidapak Services, LLC
Jul 2, 2013 VALSARTAN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling: Label Mixup: VALSARTAN, Tablet, 40 mg may have potentially been mislabeled as one of th... Class II Aidapak Services, LLC
Jul 2, 2013 LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Servi... Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled... Class II Aidapak Services, LLC
Jul 2, 2013 SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service,... Labeling:Label Mixup; SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES... Class II Aidapak Services, LLC
Jul 2, 2013 ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Servic... Labeling: Label Mixup; ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN,... Class II Aidapak Services, LLC
Jul 2, 2013 ASPIRIN Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; ASPIRIN Tablet, 325 mg may be potentially mislabeled as CHOLECALCIFEROL... Class II Aidapak Services, LLC
Jul 2, 2013 PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak... Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled ... Class II Aidapak Services, LLC
Jul 2, 2013 QUINAPRIL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL... 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 t... Class II Aidapak Services, LLC
Jul 2, 2013 TERBUTALINE SULFATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service... Labeling: Label Mixup: TERBUTALINE SULFATE, Tablet, 2.5 mg may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Ser... Labeling: Label Mixup; LANTHANUM CARBONATE Chew Tablet, 500 mg may be potentially mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, Rx only, Distrib... Labeling: Label Mixup: ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg may have poten... Class II Aidapak Services, LLC
Jul 2, 2013 VENLAFAXINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup; VENLAFAXINE HCL Tablet, 50 mg may be potentially mislabeled as sulfaSAL... Class II Aidapak Services, LLC
Jul 2, 2013 HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak S... Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislab... 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 FENOFIB... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet, Over The Counter, Distributed by: ... Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet may be potentially mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 ESTRADIOL, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup: ESTRADIOL, Tablet, 0.5 mg may have potentially been mislabeled as the foll... Class II Aidapak Services, LLC
Jul 2, 2013 LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Servi... Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled... Class II Aidapak Services, LLC
Jul 2, 2013 ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICL... 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 have potentially been mislabeled as one ... Class II Aidapak Services, LLC
Jul 2, 2013 HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup; HYDRALAZINE HCL Tablet, 25 mg may be potentially mislabeled as DOCUSATE... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distribut... Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) may be potentially mislab... Class II Aidapak Services, LLC
Jul 2, 2013 FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNIS... Class II Aidapak Services, LLC
Jul 2, 2013 PHOSPHORUS Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; PHOSPHORUS Tablet, 250 mg may be potentially mislabeled as CITALOPRAM, ... Class II Aidapak Services, LLC
Jul 2, 2013 PROPRANOLOL HCL ER, Capsule, 60 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: PROPRANOLOL HCL ER, Capsule, 60 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Ser... Labeling: Label Mixup: TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg may have potentially been mislabel... Class II Aidapak Services, LLC
Jul 2, 2013 ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service... Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 10 mg may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the fol... Class II Aidapak Services, LLC
Jul 2, 2013 CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed b... Labeling: Label Mixup; CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg may be potentially mislabeled... Class II Aidapak Services, LLC
Jul 2, 2013 CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE... Class II Aidapak Services, LLC
Jul 2, 2013 MAGNESIUM CHLORIDE, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak ... Labeling:Label Mixup; MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAM... 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 DEXAMETHASONE, Tablet, 1 mg, Rx only, Distributed by Aidapack Service, LLC, N... Labeling: Label Mixup: DEXAMETHASONE, Tablet, 1 mg may have potentially been mislabeled as the fo... Class II Aidapak Services, LLC
Jul 2, 2013 WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPa... Labeling: Label Mixup; WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabele... Class II Aidapak Services, LLC
Jul 2, 2013 SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE... Class II Aidapak Services, LLC
Jul 2, 2013 SODIUM BICARBONATE Tablet, 650 mg, Over The Counter, Distributed by: AidaPak ... Labeling: Label Mixup; SODIUM BICARBONATE Tablet, 650 mg may be potentially mislabeled as NICO... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, ... Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COM... Class II Aidapak Services, LLC
Jul 2, 2013 SODIUM CHLORIDE, Tablet, 1000 mg, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1000 mg may have potentially been mislabeled as t... Class II Aidapak Services, LLC
Jul 2, 2013 CETIRIZINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the f... Class II Aidapak Services, LLC
Jul 2, 2013 PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROG... 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.