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 | 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 | 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 | LISINOPRIL Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup; LISINOPRIL Tablet, 2.5 mg may be potentially mislabeled as RANOLAZINE E... | 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 be potentially mislabeled as ASCO... | 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 | methylPREDNISolone Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LL... | Labeling:Label Mixup; methylPREDNISolone Tablet, 4 mg may be potentially mislabeled as LEVOTHY... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FOSINOPRIL SODIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, L... | Labeling: Label Mixup: FOSINOPRIL SODIUM, Tablet, 10 mg may have potentially been mislabeled as t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak... | Labeling: Label Mixup; NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ENTECAVIR, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ISOSORBIDE MONONITRATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Servic... | Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as AS... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, Rx only, Dis... | Labeling: Label Mixup: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg may have p... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPipraz... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling:Label Mixup; ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HC... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | BENAZEPRIL HCL Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFAT... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VERAPAMIL HCL ER, Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: VERAPAMIL HCL ER, Capsule, 240 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MEXILETINE HCL, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LL... | Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as th... | Class II | Aidapak Services, LLC |
| 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 AMANTADINE... | 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 | 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 | 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 | 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 | METOPROLOL TARTRATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 50 mg may have potentially been mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, L... | Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRA... | 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 |
| 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 | BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak S... | Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as ... | 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 | ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 5... | Labeling: Label Mixup; ETODOLAC, Tablet, 400 mg may be potentially mislabeled as PANCRELIPASE ... | 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 have potentially been mislabeled as o... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASPIRIN DR EC, Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Servi... | Labeling: Label Mixup: ASPIRIN DR EC, Tablet, 81 mg may have potentially been mislabeled as one o... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | THIOTHIXENE, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: THIOTHIXENE, Capsule, 1 mg may have potentially been mislabeled as the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium), Ove... | Labeling:Label Mixup; MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium) ma... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling:Label Mixup; SELEGILINE HCL, Capsule, 5 mg may be potentially mislabeled as ITRACONAZ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0... | Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the follow... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distrib... | Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially misl... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE,... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Serv... | Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as on... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VERAPAMIL HCL, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling: Label Mixup: VERAPAMIL HCL, Tablet, 40 mg may have potentially been mislabeled as one o... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BI... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | RASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service... | Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OME... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE... | 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 PRENAT... | 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 | THYROID, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00... | Labeling: Label Mixup: THYROID, Tablet, 60 mg may have potentially been mislabeled as the followi... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PARICALCITOL, Capsule, 1 mcg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one o... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup; PARoxetine HCl, Tablet, 10 mg may be potentially mislabeled as PANTOPRA... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | quiNIDine SULFATE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup:quiNIDine SULFATE, Tablet, 200 mg may have potentially been mislabeled as t... | 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.