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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 2, 2013 | VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg, Over The Counter, Distribu... | Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg may be potentially misl... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTIN... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DESMOPRESSIN ACETATE, Tablet 0.1 mg, Rx only, Distributed by: AidaPak Service... | Labeling: Label Mixup: DESMOPRESSIN ACETATE, Tablet 0.1 mg may have potentially been mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DISULFIRAM Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup; DISULFIRAM Tablet, 250 mg may be potentially mislabeled as PYRIDOXINE H... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | azaTHIOprine, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup: azaTHIOprine, Tablet, 50 mg may have potentially been mislabeled as the fo... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: Aid... | Labeling: Label Mixup:TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg) may have potentially been m... | 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 be potentially mislabeled as SACCHARO... | 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 PERPHEN... | 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 ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Servic... | Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one o... | 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 MULT... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LETROZOLE Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... | Labeling:Label Mixup; LETROZOLE Tablet, 2.5 mg may be potentially mislabeled as METOPROLOL TAR... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, Over The Cou... | Labeling: Label Mixup: CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg may have p... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DOXAZOSIN MESYLATE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak S... | Labeling: Label Mixup: DOXAZOSIN MESYLATE, Tablet, 1 mg may have potentially been mislabeled as t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, T... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service... | Labeling:Label Mixup; ATORVASTATIN CALCIUM, Tablet, 80 mg may be potentially mislabeled as LAC... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPa... | Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as A... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak... | Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CY... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PROPRANOLOL HCL Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBAC... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL... | 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 have potentially been mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Se... | Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabe... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 00574022001, Rx only, Distributed by:... | Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 5 mcg may have potentially been mislabeled as... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | GALANTAMINE HBR ER Capsule, 24 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup; GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESC... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PANTOPRAZOLE SODIUM DR Tablet, 40 mg, Rx only, Distributed by: AidaPak Servic... | Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SE... | 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 have potentially been mislabeled as the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: ... | Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially misl... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup; DOXEPIN HCL Capsule, 150 mg may be potentially mislabeled as VALSARTAN,... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distrib... | Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potent... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SODIUM CHLORIDE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1 mg may have potentially been mislabeled as one ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,... | Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCU... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the f... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NEFAZODONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 150 mg may have potentially been mislabeled as the... | 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 | HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Ser... | Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Servic... | Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ALLOPURINOL Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup; ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCI... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LIOTHYRONINE SODIUM, Tablet 25 mcg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as gua... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Se... | Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, L... | Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMI... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, Rx only, Distribute... | Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potential... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak ... | Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as LIS... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NORTRIPTYLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 50 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | HYDROCHLOROTHIAZIDE Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service... | Labeling: Label Mixup; HYDROCHLOROTHIAZIDE Tablet, 12.5 mg may be potentially mislabeled as ch... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... | Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak ... | Labeling: Label Mixup; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), Over The Counter, Dist... | Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) may be potentially m... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | REPAGLINIDE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | EFAVIRENZ, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling:Label Mixup; COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIg... | 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.