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.

Clear

Date	Product	Reason	Class	Firm
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
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	Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured a...	Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out ...	Class II	Core Pharma 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

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.