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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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DateProductReasonClassFirm
Jul 2, 2013 COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Servi... Labeling:Label Mixup; COLESTIPOL HCL MICRONIZED Tablet, 1 g may be potentially mislabeled as r... Class II Aidapak Services, LLC
Jul 2, 2013 CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following ... 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 have potentially been mislabeled as... 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 GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one o... Class II Aidapak Services, LLC
Jul 2, 2013 ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Servi... Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALI... 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 hydrOXYzine PA... Class II Aidapak Services, LLC
Jul 2, 2013 QUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAM... Class II Aidapak Services, LLC
Jul 2, 2013 ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service,... Labeling:Label Mixup; ATORVASTATIN CALCIUM Tablet, 20 mg may be potentially mislabeled as guai... Class II Aidapak Services, LLC
Jul 2, 2013 NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTO... 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 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 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 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 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 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 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 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 CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: Aida... Labeling: Label Mixup: CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg) may have potentially been m... Class II Aidapak Services, LLC
Jul 2, 2013 CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPa... Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled a... Class II Aidapak Services, LLC
Jul 2, 2013 QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service,... Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlo... 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 VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; VENLAFAXINE Tablet, 25 mg may be potentially mislabeled as OMEPRAZOLE/S... Class II Aidapak Services, LLC
Jul 2, 2013 NIFEdipine ER, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, ... Labeling: Label Mixup: NIFEdipine ER, Tablet, 60 mg may have potentially been mislabeled as the f... 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 CYANOCOBALAMIN, Tablet, 100 mcg, Over The Counter, Distributed by: AidaPak Se... Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 100 mcg may have potentially been mislabeled as th... Class II Aidapak Services, LLC
Jul 2, 2013 PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service,... Labeling:Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOT... Class II Aidapak Services, LLC
Jul 2, 2013 HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, N... Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRI... Class II Aidapak Services, LLC
Jul 2, 2013 buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LL... Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTA... Class II Aidapak Services, LLC
Jul 2, 2013 DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Se... Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHY... Class II Aidapak Services, LLC
Jul 2, 2013 LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE ... Class II Aidapak Services, LLC
Jul 2, 2013 TACROLIMUS Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling: Label Mixup; TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXIN... 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 PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC... Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one... 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 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 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 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 ASCORBIC ACID, CHEW Tablet, 500 mg, Over The Counter, Distributed by: AidaPak... Labeling: Label Mixup: ASCORBIC ACID, CHEW Tablet, 500 mg may have potentially been mislabeled as... 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 be potentially mislabeled as DISO... Class II Aidapak Services, LLC
Jul 2, 2013 CITALOPRAM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC ... Labeling:Label Mixup; CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHL... Class II Aidapak Services, LLC
Jul 2, 2013 PYRIDOXINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Ser... Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 100 mg may have potentially been mislabeled as one... Class II Aidapak Services, LLC
Jul 2, 2013 CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak S... Labeling: Label Mixup; CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITA... Class II Aidapak Services, LLC
Jul 2, 2013 LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak ... Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLE... 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 be potentially mislabeled as the followi... Class II Aidapak Services, LLC
Jul 2, 2013 ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), Over The Counter, Distributed ... Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabele... 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

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.