Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jul 2, 2013	VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of...	Class II	Aidapak Services, LLC
Jul 2, 2013	CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, L...	Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRA...	Class II	Aidapak Services, LLC
Jul 2, 2013	METOPROLOL TARTRATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service,...	Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 50 mg may have potentially been mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	OXcarbazepine Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone ...	Class II	Aidapak Services, LLC
Jul 2, 2013	LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Servic...	Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled ...	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	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	traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, N...	Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE...	Class II	Aidapak Services, LLC
Jul 2, 2013	MEXILETINE HCL, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LL...	Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as th...	Class II	Aidapak Services, LLC
Jul 2, 2013	VERAPAMIL HCL ER, Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, ...	Labeling: Label Mixup: VERAPAMIL HCL ER, Capsule, 240 mg may have potentially been mislabeled as ...	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
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	LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPipraz...	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	DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC...	Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of t...	Class II	Aidapak Services, LLC
Jul 2, 2013	ISOSORBIDE MONONITRATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Servic...	Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as AS...	Class II	Aidapak Services, LLC
Jul 2, 2013	ENTECAVIR, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC...	Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the fol...	Class II	Aidapak Services, LLC
Jul 2, 2013	NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak...	Labeling: Label Mixup; NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled ...	Class II	Aidapak Services, LLC
Jul 2, 2013	FOSINOPRIL SODIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, L...	Labeling: Label Mixup: FOSINOPRIL SODIUM, Tablet, 10 mg may have potentially been mislabeled as t...	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	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	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	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	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	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	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	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	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	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	chlorproMAZINE HCl, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service,...	Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 100 mg may have potentially been mislabeled as...	Class II	Aidapak Services, LLC
Jul 2, 2013	LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by:...	Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled a...	Class II	Aidapak Services, LLC
Jul 2, 2013	MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 6...	Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as OMEGA-...	Class II	Aidapak Services, LLC
Jul 2, 2013	ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Ser...	Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as ...	Class II	Aidapak Services, LLC
Jul 2, 2013	LACTASE ENZYME Tablet, 3000 units, Over The Counter, Distributed by: AidaPak ...	Labeling: Label Mixup; LACTASE ENZYME Tablet, 3000 units may be potentially mislabeled as BENZ...	Class II	Aidapak Services, LLC
Jul 2, 2013	DIGOXIN, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC ...	Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the follo...	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 medroxyPROG...	Class II	Aidapak Services, LLC
Jul 2, 2013	CETIRIZINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the f...	Class II	Aidapak Services, LLC
Jul 2, 2013	SODIUM CHLORIDE, Tablet, 1000 mg, Over The Counter, Distributed by: AidaPak S...	Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1000 mg may have potentially been mislabeled as t...	Class II	Aidapak Services, LLC
Jul 2, 2013	LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, ...	Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COM...	Class II	Aidapak Services, LLC
Jul 2, 2013	SODIUM BICARBONATE Tablet, 650 mg, Over The Counter, Distributed by: AidaPak ...	Labeling: Label Mixup; SODIUM BICARBONATE Tablet, 650 mg may be potentially mislabeled as NICO...	Class II	Aidapak Services, LLC
Jul 2, 2013	SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE...	Class II	Aidapak Services, LLC
Jul 2, 2013	WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPa...	Labeling: Label Mixup; WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabele...	Class II	Aidapak Services, LLC
Jul 2, 2013	DEXAMETHASONE, Tablet, 1 mg, Rx only, Distributed by Aidapack Service, LLC, N...	Labeling: Label Mixup: DEXAMETHASONE, Tablet, 1 mg may have potentially been mislabeled as the fo...	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	MAGNESIUM CHLORIDE, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak ...	Labeling:Label Mixup; MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAM...	Class II	Aidapak Services, LLC
Jul 2, 2013	CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, ...	Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE...	Class II	Aidapak Services, LLC
Jul 2, 2013	CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed b...	Labeling: Label Mixup; CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg may be potentially mislabeled...	Class II	Aidapak Services, LLC
Jul 2, 2013	ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LL...	Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the fol...	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.