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Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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DateProductReasonClassFirm
Jul 2, 2013 CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, Distributed by: AidaPak Se... Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Table... 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 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 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 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 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 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 MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, L... Labeling:Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY A... Class II Aidapak Services, LLC
Jul 2, 2013 HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Se... Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as ... 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 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 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 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 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 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 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 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 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 METHYLERGONOVINE MALEATE Tablet, 0.2 mg, Rx only, Distributed by: AidaPak Ser... Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ... 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 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
Jul 2, 2013 NORTRIPTYLINE HCL, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 10 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 ACYCLOVIR, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: ACYCLOVIR, Capsule, 200 mg may have potentially been mislabeled as one of ... 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 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 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 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 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 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 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 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 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 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 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 rifAXIMin Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling:Label Mixup; rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL,... Class II Aidapak Services, LLC
Jul 2, 2013 TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Serv... Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as o... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM POLYCARBOPHIL, Tablet, 625 mg, Over The Counter, Distributed by: Aida... Labeling: Label Mixup: CALCIUM POLYCARBOPHIL, Tablet, 625 mg may have potentially been mislabeled... Class II Aidapak Services, LLC
Jul 2, 2013 PHENobarbital, Tablet, 64.8 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: PHENobarbital, Tablet, 64.8 mg may have potentially been mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 GALANTAMINE HBr ER, Capsule, 8 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup; GALANTAMINE HBr ER, Capsule, 8 mg may be potentially mislabeled as FAM... Class II Aidapak Services, LLC
Jul 2, 2013 NEBIVOLOL HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of... Class II Aidapak Services, LLC
Jul 2, 2013 clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak... Labeling: Label Mixup: clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been misl... Class II Aidapak Services, LLC
Jul 2, 2013 ESTERIFIED ESTROGENS Tablet, 0.625 mg, Rx only, Distributed by: AidaPak Servi... Labeling:Label Mixup; ESTERIFIED ESTROGENS, Tablet, 0.625 mg may be potentially mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg, Rx only, Distributed by: AidaPak Se... Labeling: Label Mixup: CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg may have potentially been mislabe... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distribute... Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-lab... Class II Aidapak Services, LLC
Jul 2, 2013 MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: MEXILETINE HCL, Capsule, 150 mg may have potentially been mislabeled as th... Class II Aidapak Services, LLC
Jul 2, 2013 NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of ... Class II Aidapak Services, LLC
Jul 2, 2013 FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL ... 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.