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.

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DateProductReasonClassFirm
Jul 2, 2013 THIORIDAZINE HCL, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: THIORIDAZINE HCL, Tablet, 50 mg may have potentially been mislabeled as th... Class II Aidapak Services, LLC
Jul 2, 2013 MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Servi... Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 THIAMINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Servi... Labeling: Label Mixup: THIAMINE HCL, Tablet, 100 mg may have potentially been mislabeled as one o... 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 NEFAZODONE HCL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 200 mg may have potentially been mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of t... 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 DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, L... Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOT... Class II Aidapak Services, LLC
Jul 2, 2013 FOSINOPRIL SODIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling:Label Mixup; FOSINOPRIL SODIUM, Tablet, 20 mg may be potentially mislabeled as TOLTER... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distrib... Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mis... Class II Aidapak Services, LLC
Jul 2, 2013 PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed... Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially... Class II Aidapak Services, LLC
Jul 2, 2013 BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service... Labeling: Label Mixup; BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIF... Class II Aidapak Services, LLC
Jul 2, 2013 prednisoLONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC... Labeling: Label Mixup; prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER ... 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 PSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Ser... Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-... Class II Aidapak Services, LLC
Jul 2, 2013 OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling:Label Mixup; OLANZapine, Tablet, 7.5 mg may be potentially mislabeled as LEVOTHYROXIN... Class II Aidapak Services, LLC
Jul 2, 2013 LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), Rx only, Distributed ... Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg) may have potentiall... Class II Aidapak Services, LLC
Jul 2, 2013 guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one o... Class II Aidapak Services, LLC
Jul 2, 2013 BISOPROLOL FUMARATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, L... Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTR... Class II Aidapak Services, LLC
Jul 2, 2013 DILTIAZEM HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup: DILTIAZEM HCL, Tablet, 120 mg, may have potentially been mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 FOSINOPRIL SODIUM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling:Label Mixup; FOSINOPRIL SODIUM Tablet, 10 mg may be potentially mislabeled as CALCITR... Class II Aidapak Services, LLC
Jul 2, 2013 LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), Rx only, Distributed by... Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mi... Class II Aidapak Services, LLC
Jul 2, 2013 PIOGLITAZONE HCL, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as on... Class II Aidapak Services, LLC
Jul 2, 2013 CHLORTHALIDONE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup: CHLORTHALIDONE, Tablet, 50 mg may have potentially been mislabeled as the ... Class II Aidapak Services, LLC
Jul 2, 2013 PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECA... Class II Aidapak Services, LLC
Jul 2, 2013 PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed... Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially... Class II Aidapak Services, LLC
Jul 2, 2013 LOVASTATIN, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup: LOVASTATIN, Tablet, 20 mg may have potentially been mislabeled as one of t... Class II Aidapak Services, LLC
Jul 2, 2013 THYROID, Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00... Labeling: Label Mixup: THYROID, Tablet, 30 mg may have potentially been mislabeled as one of the ... Class II Aidapak Services, LLC
Jul 2, 2013 DESLORATADINE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup: DESLORATADINE, Tablet, 5 mg may have potentially been mislabeled as the fo... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule, Over The Counter, Distributed by:... Labeling: Label Mixup; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule may be potentially mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 ESTROPIPATE, Tablet, 0.75 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: ESTROPIPATE, Tablet, 0.75 mg may have potentially been mislabeled as the f... Class II Aidapak Services, LLC
Jul 2, 2013 ASPIRIN, CHEW Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Servic... Labeling: Label Mixup: ASPIRIN, CHEW Tablet, 81 mg may have potentially been mislabeled as one of... Class II Aidapak Services, LLC
Jul 2, 2013 glyBURIDE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of t... Class II Aidapak Services, LLC
Jul 2, 2013 hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup; hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleT... Class II Aidapak Services, LLC
Jul 2, 2013 amLODIPine BESYLATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: amLODIPine BESYLATE, Tablet, 5 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 5... Labeling: Label Mixup; TORSEMIDE, Tablet, 10 mg may be potentially mislabeled as PYRIDOXINE HC... Class II Aidapak Services, LLC
Jul 2, 2013 MULTIVITAMIN/MULTIMINERAL Chew Tablet, Over The Counter, Distributed by: Aida... Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Chew Tablet may be potentially mislabeled as L... Class II Aidapak Services, LLC
Jul 2, 2013 traMADol HCl Tablet, 25 mg (1/2 of 50 mg), Rx only, Distributed by: AidaPak S... Labeling:Label Mixup; traMADol HCl Tablet, 25 mg (1/2 of 50 mg) may be potentially mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 CYPROHEPTADINE HCL Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling:Label Mixup; CYPROHEPTADINE HCL Tablet, 4 mg may be potentially mislabeled as ACARBOS... Class II Aidapak Services, LLC
Jul 2, 2013 VITAMIN B COMPLEX W/C Capsule, Over The Counter, Distributed by: AidaPak Serv... Labeling:Label Mixup; VITAMIN B COMPLEX W/C Capsule may be potentially mislabeled as SODIUM CH... Class II Aidapak Services, LLC
Jul 2, 2013 OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed ... Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially ... Class II Aidapak Services, LLC
Jul 2, 2013 MESALAMINE DR, Capsule, 400 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the... Class II Aidapak Services, LLC
Jul 2, 2013 DOXYCYCLINE HYCLATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Servic... Labeling: Label Mixup: DOXYCYCLINE HYCLATE, Capsule, 100 mg may have potentially been mislabeled ... Class II Aidapak Services, LLC
Jul 2, 2013 ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, L... Labeling: Label Mixup: ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as one of the... Class II Aidapak Services, LLC
Jul 2, 2013 LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, ... Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 25 mg may have potentially been mislabeled as ... Class II Aidapak Services, LLC
Jul 2, 2013 FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC,... Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCREL... Class II Aidapak Services, LLC
Jul 2, 2013 BUMETANIDE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: BUMETANIDE, Tablet, 0.5 mg, Rx only may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 CapsuleTOPRIL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 25 mg may have potentially been mislabeled as the f... Class II Aidapak Services, LLC
Jul 2, 2013 ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, R... Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg... Class II Aidapak Services, LLC
Jul 2, 2013 PRAMIPEXOLE DI-HCL Tablet, 0.25 mg, Rx only, Distributed by: AidaPak Service,... Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TA... 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.