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 | ZONISAMIDE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup; ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADION... | 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 QUETIAPINE FU... | 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 be potentially mislabeled as VITA... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NIACIN, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LL... | Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the followi... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Se... | Labeling: Label Mixup; DOXYCYCLINE MONOHYDRATE Capsule, 100 mg may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NIACIN ER, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGE... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule, 100 mg, Rx only, Distribut... | Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentia... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DICYCLOMINE HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup: DICYCLOMINE HCL, Tablet, 20 mg may have potentially been mislabeled as the... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ALBUTEROL SULFATE ER, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Serv... | Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Servi... | Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as CO... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | BUMETANIDE, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... | Labeling: Label Mixup: BUMETANIDE, Tablet, 1 mg may have potentially been mislabeled as the follo... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion H... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Se... | Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabe... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | METOPROLOL SUCCINATE ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Serv... | Labeling:Label Mixup; METOPROLOL SUCCINATE ER, Tablet, 200 mg may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ISONIAZID, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: ISONIAZID, Tablet, 300 mg may have potentially been mislabeled as one of t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/... | Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 m... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MESALAMINE CR Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPR... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | BUPRENORPHINE HCL SL, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units, Over The Counter, Distributed ... | Labeling: Label Mixup; D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units may be potentially mislabele... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | IMIPRAMINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LOSARTAN POTASSIUM Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, L... | Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DOCU... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distribute... | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabe... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | HYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one o... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LIOTHYRONINE SODIUM, Tablet, 5 mcg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 5 mcg may be potentially mislabeled as HYDR... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | amLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service,... | Labeling:Label Mixup; amLODIPine BESYLATE, Tablet, 10 mg may be potentially mislabeled as FINA... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FEXOFENADINE HCL, Tablet 180 mg, Rx only, Distributed by: AidaPak Service, LL... | Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIV... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MESALAMINE CR Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | glyBURIDE, Tablet, 1.25 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: glyBURIDE, Tablet, 1.25 mg may have potentially been mislabeled as one of ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Serv... | Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabele... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VALSARTAN, Tablet, 320 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: VALSARTAN, Tablet, 320 mg may have potentially been mislabeled as the foll... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Servi... | Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as C... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ATORVASTATIN CALCIUM, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service... | Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 40 mg may have potentially been mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LEVOTHYROXINE SODIUM, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Servi... | Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 125 mcg may have potentially been mislabeled... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Servi... | Labeling: Label Mixup; PYRIDOXINE HCL Tablet, 50 mg may be potentially mislabeled as CALCIUM C... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by... | Labeling: Label Mixup: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg may have potentially been misl... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Count... | Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be poten... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VENLAFAXINE HCL, Tablet, 75 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 75 mg may have potentially been mislabeled as the... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LOSARTAN POTASSIUM, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MYCOPHENOLATE MOFETIL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Servi... | Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as th... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FLUVASTATIN SODIUM, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ERYTHROMYCIN DR EC Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup; ERYTHROMYCIN DR EC Tablet, 250 mg may be potentially mislabeled as meth... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | buPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Servi... | Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as M... | 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.