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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 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 GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one o... 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 DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as o... 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 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 MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, L... Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMP... 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 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 MINOCYCLINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, L... Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 100 mg may have potentially been mislabeled as t... Class II Aidapak Services, LLC
Jul 2, 2013 NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the fol... 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 VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of... Class II Aidapak Services, LLC
Jul 2, 2013 ZINC SULFATE Capsule, 220 mg, Over The Counter, Distributed by: AidaPak Servi... Labeling:Label Mixup; ZINC SULFATE Capsule, 220 mg may be potentially mislabeled as CALCIUM AC... 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 mislabeled... 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
Jul 2, 2013 FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of... Class II Aidapak Services, LLC
Jul 2, 2013 SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of ... 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 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 PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Servic... Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FO... Class II Aidapak Services, LLC
Jul 2, 2013 LORATADINE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLAT... 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 medroxyPROGESTERone ACETATE Tablet, 10 mg, Rx only, Distributed by: AidaPak S... Labeling:Label Mixup; medroxyPROGESTERone ACETATE, Tablet, 10 mg may be potentially mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed ... Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mi... 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 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 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 diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as AT... 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 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 PIOGLIT... Class II Aidapak Services, LLC
Jul 2, 2013 FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, ... Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PH... 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 mislabeled as N... 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 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 AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as on... Class II Aidapak Services, LLC
Jul 2, 2013 MINOXIDIL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup:MINOXIDIL, Tablet, 2.5 mg may have potentially been mislabeled as the follo... Class II Aidapak Services, LLC
Jul 2, 2013 TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of t... Class II Aidapak Services, LLC
Jul 2, 2013 SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 sitaGLIPtin PHOSPHATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Servic... Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled 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 VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of th... 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 MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg, Over The Counter, Distributed b... Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg may have potentially been mis... Class II Aidapak Services, LLC
Jul 2, 2013 AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distrib... Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mis... 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 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 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 NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN ... 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.