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 | MERCapsuleTOPURINE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, ... | Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the follo... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaP... | Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VENLAFAXINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LL... | Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN... | 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 | CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following d... | 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 | CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The... | Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be p... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by... | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mi... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak ... | Labeling: Label Mixup: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been misla... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NIACIN TR, Tablet, 1000 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: NIACIN TR, Tablet, 1000 mg may have potentially been mislabeled as the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ACARBOSE, Tablet 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23... | Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS G... | 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 | VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, L... | Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLU... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROP... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | RILUZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0... | Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the follow... | 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 be potentially mis-labeled as t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASCORBIC ACID, Tablet, 250 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Ser... | Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as RE... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NIACIN TR, Tablet, 750 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: NIACIN TR, Tablet, 750 mg may have potentially been mislabeled as the foll... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PIOGLITAZONE, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TRIFLUOPERAZINE HCL, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, Rx only, Distributed by: Aida... | Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been m... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TEMAZEPAM, Capsule, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CapsuleTOPRIL, Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 12.5 mg may have potentially been mislabeled as the... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distribu... | Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially misla... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service... | Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of ... | 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 have potentially been mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, T... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MINOCYCLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LL... | Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 50 mg may have potentially been mislabeled as th... | 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 be potentially mislabeled as RIBAVIRIN, ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VITAMIN B COMPLEX, Capsule, 0 mg, Over The Counter, Distributed by: AidaPak S... | Labeling: Label Mixup: VITAMIN B COMPLEX, Capsule, 0 mg may have potentially been mislabeled as t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0... | Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the follow... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg, Over The Counter, Distri... | Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg may have potentially b... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | carBAMazepine ER, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, L... | Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as o... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLU... | 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 LACTOBAC... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, ... | Labeling:Label Mixup; CINACALCET HCL, Tablet, 30 mg may be potentially mislabeled as ACETAMINO... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaP... | Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: A... | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially bee... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distrib... | Labeling: Label Mixup; CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg may be potentially misl... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PIMOZIDE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57... | Labeling:Label Mixup; PIMOZIDE Tablet, 2 mg may be potentially mislabeled as DULoxetine HCl DR... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup; GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACIL... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VALSARTAN, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: VALSARTAN, Tablet, 160 mg may have potentially been mislabeled as one of t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CLINDAMYCIN HCL, Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, L... | Labeling: Label Mixup: CLINDAMYCIN HCL, Capsule, 300 mg may have potentially been mislabeled as t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, Rx only, Distributed... | Labeling: Label Mixup: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg may have potential... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ATENOLOL Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Ser... | Labeling:Label Mixup; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as ... | 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.