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 PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 NIFEdipine ER, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: NIFEdipine ER, Tablet, 60 mg may have potentially been mislabeled as the f... Class II Aidapak Services, LLC
Jul 2, 2013 VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; VENLAFAXINE Tablet, 25 mg may be potentially mislabeled as OMEPRAZOLE/S... 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 QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service,... Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlo... Class II Aidapak Services, LLC
Jul 2, 2013 CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPa... Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: Aida... Labeling: Label Mixup: CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg) may have potentially been m... Class II Aidapak Services, LLC
Jul 2, 2013 PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), Rx only, Distributed by: Aid... Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg) may have potentially been ... Class II Aidapak Services, LLC
Jul 2, 2013 PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup:PROGESTERONE, Capsule, 100 mg may have potentially been mislabeled as the ... Class II Aidapak Services, LLC
Jul 2, 2013 GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg, Over The Counter, Distributed... Labeling:Label Mixup; GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg may be potentially mislabele... Class II Aidapak Services, LLC
Jul 2, 2013 MYCOPHENOLIC ACID DR, Tablet, 180 mg, Rx only, Distributed by: AidaPak Servic... Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled ... Class II Aidapak Services, LLC
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 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 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 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 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 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 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 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 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 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 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 NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as... 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 be potentially mislabeled as the following ... Class II Aidapak Services, LLC
Jul 2, 2013 COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Servi... Labeling:Label Mixup; COLESTIPOL HCL MICRONIZED Tablet, 1 g may be potentially mislabeled as r... 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

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.