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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 traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHAS... 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 chlordiazePOXIDE HCl, Capsule, 25 mg, Rx only, Distributed by: AidaPak Servic... Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled ... 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 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 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 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 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 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 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 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 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 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 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 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 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 CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, ... Class II Aidapak Services, LLC
Jul 2, 2013 COENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Serv... Labeling: Label Mixup; COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELI... 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 PRENATAL... Class II Aidapak Services, LLC
Jul 2, 2013 BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Serv... Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabele... Class II Aidapak Services, LLC
Jul 2, 2013 SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTY... Class II Aidapak Services, LLC
Jul 2, 2013 SOTALOL HCL, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the fo... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of t... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Dist... Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) may be potentially m... Class II Aidapak Services, LLC
Jul 2, 2013 FLUVASTATIN, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the fo... Class II Aidapak Services, LLC
Jul 2, 2013 VENLAFAXINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 25 mg may have potentially been mislabeled as one... Class II Aidapak Services, LLC
Jul 2, 2013 RIBAVIRIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, T... Class II Aidapak Services, LLC
Jul 2, 2013 OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed b... Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially m... Class II Aidapak Services, LLC
Jul 2, 2013 ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), Over The Counter, Distributed ... Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabele... 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 be potentially mislabeled as the followi... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak ... Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLE... 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 be potentially mislabeled as VITA... Class II Aidapak Services, LLC
Jul 2, 2013 PYRIDOXINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Ser... Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 100 mg may have potentially been mislabeled as one... Class II Aidapak Services, LLC
Jul 2, 2013 CITALOPRAM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling:Label Mixup; CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHL... Class II Aidapak Services, LLC
Jul 2, 2013 LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DISO... Class II Aidapak Services, LLC
Jul 2, 2013 ASCORBIC ACID, CHEW Tablet, 500 mg, Over The Counter, Distributed by: AidaPak... Labeling: Label Mixup: ASCORBIC ACID, CHEW Tablet, 500 mg may have potentially been mislabeled as... Class II Aidapak Services, LLC
Jul 2, 2013 CALCIUM ACETATE, Tablet, 667 mg, Over The Counter, Distributed by: AidaPak Se... Labeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as on... Class II Aidapak Services, LLC
Jul 2, 2013 tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak S... Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter, Distributed by: AidaPa... Labeling: Label Mixup: VITAMIN B COMPLEX W/C, Tablet, 0 mg may have potentially been mislabeled a... 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 PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/MULTIMINERAL Tablet, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as QUEt... Class II Aidapak Services, LLC
Jul 2, 2013 RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: RALTEGRAVIR, Tablet, 400 mg may be potentially mis-labeled as one of the f... 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 be potentially mislabeled as LEVOTHYROXIN... Class II Aidapak Services, LLC
Jul 2, 2013 LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE ... Class II Aidapak Services, LLC
Jul 2, 2013 DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Se... Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHY... Class II Aidapak Services, LLC
Jul 2, 2013 buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTA... Class II Aidapak Services, LLC
Jul 2, 2013 HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRI... Class II Aidapak Services, LLC
Jul 2, 2013 PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service,... Labeling:Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOT... Class II Aidapak Services, LLC
Jul 2, 2013 CYANOCOBALAMIN, Tablet, 100 mcg, Over The Counter, Distributed by: AidaPak Se... Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 100 mcg may have potentially been mislabeled as th... 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.