Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

1,293 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Niacin Tr

Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-500-2014
Class II · Moderate risk

Itraconazole

Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-499-2014
Class II · Moderate risk

GALANTAMINE HBr ER

Labeling: Label Mixup; GALANTAMINE HBr ER, Capsule, 8 mg may be potentially mislabeled as FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003508, EXP: 6/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-498-2014
Class II · Moderate risk

Melatonin

Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400

Terminated Labeling / mix-up Aidapak Services, LLC D-497-2014
Class II · Moderate risk

Omega-3 Fatty Acid

Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD21790_70, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-496-2014
Class II · Moderate risk

Naproxen

Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP: 5/20/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD67989_13, EXP: 5/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-495-2014
Class II · Moderate risk

Melatonin

Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as QUETIAPINE FUMARATE, Tablet, 12.5 MG (1/2 of 25 MG), NDC 47335090288, Pedigree: AD21790_79, EXP: 5/1/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD73521_13, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-494-2014
Class II · Moderate risk

Bisacodyl Ec

Labeling: Label Mixup; BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD37056_13, EXP: 5/10/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-493-2014
Class II · Moderate risk

Magnesium Chloride Dr

Labeling: Label Mixup; MAGNESIUM CHLORIDE DR, Tablet, 64 mg may be potentially mislabeled as SELEGILINE HCL, Capsule, 5 mg, NDC 67253070006, Pedigree: AD54549_19, EXP: 5/20/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD70639_10, EXP: 5/29/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-492-2014
Class II · Moderate risk

Docusate Sodium

Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: AD65475_13, EXP: 5/28/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD68025_1, EXP: 5/28/2014; PANTOPRAZOLE SODIUM DR, Tablet, 40 mg, NDC 64679043402, Pedigree: AD37063_10, EXP: 5/13/2014; DOCUSATE SODIUM

Terminated Labeling / mix-up Aidapak Services, LLC D-491-2014
Class II · Moderate risk

Ferrous Sulfate

Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD54549_16, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-490-2014
Class II · Moderate risk

Ferrous Sulfate

Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-489-2014
Class II · Moderate risk

Cholecalciferol

Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014; LEVOTHYROXINE SODIUM, Tablet, 175

Terminated Labeling / mix-up Aidapak Services, LLC D-488-2014
Class II · Moderate risk

Cholecalciferol

Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD70629_16, EXP: 5/29/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W003540, EXP: 6/21/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD52993_16, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-487-2014
Class II · Moderate risk

Cholecalciferol

Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003459, EXP: 6/20/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: AD32328_8, EXP: 5/9/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002715, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 49884006601

Terminated Labeling / mix-up Aidapak Services, LLC D-486-2014
Class II · Moderate risk

Cholecalciferol

Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053

Terminated Labeling / mix-up Aidapak Services, LLC D-485-2014
Class II · Moderate risk

Glucosamine/Chondroitin Ds

Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD60211_11, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-484-2014
Class II · Moderate risk

diphenhydrAMINE HCl

Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg

Terminated Labeling / mix-up Aidapak Services, LLC D-483-2014
Class II · Moderate risk

Multivitamin/Multimineral

Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as LISINOPRIL, Tablet, 2.5 mg, NDC 64679092701, Pedigree: AD25264_4, EXP: 5/3/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-482-2014
Class II · Moderate risk

Glucosamine/Chondroitin Ds

Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: AD22865_4, EXP: 5/2/2014; PREGABALIN, Capsule, 25 mg, NDC 00071101268, Pedigree: W003121, EXP: 6/13/2014; MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD73521_10, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-481-2014
Class II · Moderate risk

Zinc Sulfate

Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-480-2014
Class II · Moderate risk

Zinc Sulfate

Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-479-2014
Class II · Moderate risk

Prenatal Multivitamin/Multimineral

Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50 mg, NDC 00075770060, Pedigree: AD62992_11, EXP: 5/23/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003093, EXP: 6/13/2014; NIACIN TR, Capsule, 250 mg, NDC 00904062960, Pedigree: W003478, EXP: 6/20/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 009045

Terminated Labeling / mix-up Aidapak Services, LLC D-478-2014
Class II · Moderate risk

Guaifenesin

Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, EXP: 6/7/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-477-2014
Class II · Moderate risk

Acetaminophen/ Aspirin/ Caffeine

Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-476-2014

Recalls by year