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 | 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 one of ... | 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 | ARIPiprazole Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling:Label Mixup; ARIPiprazole, Tablet, 15 mg may be potentially mislabeled as ATOMOXETINE... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ANAGRELIDE HCL, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LL... | Labeling: Label Mixup: ANAGRELIDE HCL, Capsule, 0.5 mg may have potentially been mislabeled as th... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: Aid... | Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabel... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by:... | Labeling: Label Mixup: BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg may have potentially been misla... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetin... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PREGABALIN, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: PREGABALIN, Capsule, 25 mg may have potentially been mislabeled as one of ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PIROXICAM, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: PIROXICAM, Capsule, 10 mg may have potentially been mislabeled as the foll... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CRANBERRY Tablet, 450 mg, Over The Counter, Distributed by: AidaPak Service, ... | Labeling:Label Mixup; CRANBERRY Tablet, 450 mg may be potentially mislabeled as METOPROLOL SUC... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak ... | Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | IBUPROFEN, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling:Label Mixup; IBUPROFEN, Tablet, 400 mg may be potentially mislabeled as ASPIRIN, Tabl... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASPIRIN EC, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service... | Labeling: Label Mixup: ASPIRIN EC, Tablet, 325 mg may have potentially been mislabeled as one of ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling:Label Mixup; FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MU... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... | Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIP... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: IRBESARTAN, Tablet, 150 mg may have potentially been mislabeled as the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE PO... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MIDODRINE HCL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup: MIDODRINE HCL, Tablet, 2.5 mg may have potentially been mislabeled as the ... | 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 be potentially mislabeled as HYOSCYAMIN... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ACARBOSE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0... | Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the follow... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MAGNESIUM CHLORIDE DR, Tablet, 64 mg, Over The Counter, Distributed by: AidaP... | Labeling: Label Mixup; MAGNESIUM CHLORIDE DR, Tablet, 64 mg may be potentially mislabeled as S... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CHOLECALCIFEROL Capsule, 50000 units, Over The Counter, Distributed by: AidaP... | Labeling: Label Mixup; CHOLECALCIFEROL Capsule, 50000 units may be potentially mislabeled as F... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Servic... | Labeling: Label Mixup: HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg may have potentially been mislabeled ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | guanFACINE HC, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup: guanFACINE HC, Tablet, 1 mg may have potentially been mislabeled as one of... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CANDESARTAN CILEXETIL, Tablet, 16 mg, Rx only, Distributed by: AidaPak Servic... | Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | EXEMESTANE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: EXEMESTANE, Tablet, 25 mg may be potentially mislabeled as the following d... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SIMVASTATIN, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: SIMVASTATIN, Tablet, 5 mg may have potentially been mislabeled as the foll... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | predniSONE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup:predniSONE, Tablet, 20 mg may have potentially been mislabeled as the follo... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SOTALOL HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the fo... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOX... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LITHIUM CARBONATE ER, Tablet, 300 mg, Rx only, Distributed by: AidaPak Servic... | Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the f... | 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 D... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFER... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service,... | Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZA... | 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 mislabel as NO... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DOXYCYCLINE HYCLATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup; DOXYCYCLINE HYCLATE, Tablet, 100 mg may be potentially mislabeled as DE... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ESCITALOPRAM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the foll... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00... | Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VENLAFAXINE HCL ER, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service... | Labeling: Label Mixup: VENLAFAXINE HCL ER, Capsule, 150 mg may have potentially been mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | DESIPRAMINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup; DESIPRAMINE HCL Tablet, 50 mg may be potentially mislabeled as clomiPRA... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | REPAGLINIDE, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: REPAGLINIDE, Tablet, 1 mg may have potentially been mislabeled as one of t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed ... | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | EFAVIRENZ, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the foll... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SOLIFENACIN SUCCINATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup; SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BRO... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as ... | 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 | 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 | MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), Over The Counter... | Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) may be potentia... | 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.