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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 TERAZOSIN HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: TERAZOSIN HCL, Capsule, 5 mg may have potentially been mislabeled as the f... Class II Aidapak Services, LLC
Jul 2, 2013 METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: ... Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially misl... Class II Aidapak Services, LLC
Jul 2, 2013 PROPAFENONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as th... Class II Aidapak Services, LLC
Jul 2, 2013 FINASTERIDE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling: Label Mixup; FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tab... Class II Aidapak Services, LLC
Jul 2, 2013 METHAZOLAMIDE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the f... Class II Aidapak Services, LLC
Jul 2, 2013 CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPa... Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as P... Class II Aidapak Services, LLC
Jul 2, 2013 RIVAROXABAN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; RIVAROXABAN Tablet, 20 mg may be potentially mislabeled as VENLAFAXINE ... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units, Over The Counter... Labeling: Label Mixup: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units may be potenti... Class II Aidapak Services, LLC
Jul 2, 2013 PRAMIPEXOLE DI-HCL Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPRO... Class II Aidapak Services, LLC
Jul 2, 2013 FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the fo... Class II Aidapak Services, LLC
Jul 2, 2013 PYRIDOXINE HCL, Tablet, 25 mg, Over The Counter, Distributed by: AidaPak Serv... Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 25 mg may have potentially been mislabeled as the ... Class II Aidapak Services, LLC
Jul 2, 2013 ACYCLOVIR, Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup: ACYCLOVIR, Tablet, 800 mg may have potentially been mislabeled as the foll... 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 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 VITAMIN B COMPLEX, Tablet Over The Counter, Distributed by: AidaPak Service, ... Labeling: Label Mixup; VITAMIN B COMPLEX Tablet may be potentially mislabeled as OMEPRAZOLE/SO... Class II Aidapak Services, LLC
Jul 2, 2013 MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRA... Class II Aidapak Services, LLC
Jul 2, 2013 QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: ... Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially misl... Class II Aidapak Services, LLC
Jul 2, 2013 OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE EN... Class II Aidapak Services, LLC
Jul 2, 2013 PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Servi... Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one... Class II Aidapak Services, LLC
Jul 2, 2013 metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 F... 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 be potentially mislabeled as ATROP... Class II Aidapak Services, LLC
Jul 2, 2013 METOPROLOL TARTRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 25 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 ASCORBIC ACID Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Servi... Labeling:Label Mixup; ASCORBIC ACID Tablet, 500 mg may be potentially mislabeled as FEBUXOSTAT... Class II Aidapak Services, LLC
Jul 2, 2013 BENAZEPRIL HCL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE... Class II Aidapak Services, LLC
Jul 2, 2013 LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Servic... Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled ... Class II Aidapak Services, LLC
Jul 2, 2013 chlorproMAZINE HCl, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 100 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTO... Class II Aidapak Services, LLC
Jul 2, 2013 TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaP... Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled ... Class II Aidapak Services, LLC
Jul 2, 2013 METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: ... Labeling:Label Mixup; METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially misla... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter,... Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentia... Class II Aidapak Services, LLC
Jul 2, 2013 ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPI... Class II Aidapak Services, LLC
Jul 2, 2013 SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPa... Labeling: Label Mixup: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg may have potentially been mis... Class II Aidapak Services, LLC
Jul 2, 2013 DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: ... 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 be potentially mislabeled as guai... Class II Aidapak Services, LLC
Jul 2, 2013 NABUMETONE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the fol... Class II Aidapak Services, LLC
Jul 2, 2013 ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak ... Labeling: Label Mixup: ACETAMINOPHEN, CHEW Tablet, 80 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 OXcarbazepine Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone ... 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 PHENYTOIN SODIUM ER, Capsule, 30 mg, Rx only, Distributed by: AidaPak Service... Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 QUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAM... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by:... Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 6... Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as OMEGA-... Class II Aidapak Services, LLC
Jul 2, 2013 MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PA... Class II Aidapak Services, LLC
Jul 2, 2013 SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B CO... Class II Aidapak Services, LLC
Jul 2, 2013 ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Servi... Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALI... 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 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 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 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 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

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.