Browse Drug Recalls
2,085 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,085 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 2,085 FDA drug recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 F... | 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 mislabeled as one... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE EN... | 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 | 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 | 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 | 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 | LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Servi... | Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ACYCLOVIR, Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: ACYCLOVIR, Tablet, 800 mg may have potentially been mislabeled as the foll... | 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 | FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,... | Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the fo... | 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 | CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units, Over The Counter... | Labeling: Label Mixup: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units may be potenti... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | RIVAROXABAN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup; RIVAROXABAN Tablet, 20 mg may be potentially mislabeled as VENLAFAXINE ... | Class II | Aidapak Services, LLC |
| 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 | 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 | FINASTERIDE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... | Labeling: Label Mixup; FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tab... | 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 | 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 misl... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TERAZOSIN HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling: Label Mixup: TERAZOSIN HCL, Capsule, 5 mg may have potentially been mislabeled as the f... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LEVOTHYROXINE SODIUM, Tablet, 137 mcg, Rx only, Distributed by: AidaPak Servi... | Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled... | 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 | MYCOPHENOLIC ACID DR, Tablet, 180 mg, Rx only, Distributed by: AidaPak Servic... | Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, Distributed by: AidaPak Se... | Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Table... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg, Over The Counter, Distributed... | Labeling:Label Mixup; GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg 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 have potentially been mislabeled as the ... | 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 | 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 | CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), Rx only, Distributed by: Aid... | Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg) may have potentially been ... | 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 | PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.