Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2013

Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

2,085 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2013 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
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
Class II · Moderate risk

Pseudoephedrine HCL

Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, EXP: 6/7/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-475-2014
Class II · Moderate risk

Calcium Citrate

Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD46265_10, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-474-2014
Class II · Moderate risk

Calcium Citrate

Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) may be potentially mislabeled as TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD21858_10, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-473-2014
Class II · Moderate risk

Calcium Citrate

Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: W003750, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-472-2014
Class II · Moderate risk

Calcium Citrate

Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002767, EXP: 6/6/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD60240_20, EXP: 5/22/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: AD73521_25, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-471-2014
Class II · Moderate risk

Calcium Citrate

Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium may be potentially mislabeled as TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, NDC 00378135201, Pedigree: AD28333_4, EXP: 5/6/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-470-2014
Class II · Moderate risk

Pseudoephedrine HCL

Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC 49348041010, Pedigree: AD52993_28, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-469-2014
Class II · Moderate risk

Coenzyme Q-10

Labeling: Label Mixup; COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W002819, EXP: 6/7/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-468-2014
Class II · Moderate risk

Niacin Tr

Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-467-2014
Class II · Moderate risk

Cyanocobalamin

Labeling: Label Mixup; CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD21846_43, EXP: 5/1/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD46257_22, EXP: 5/15/2014; chlorproMAZINE HCl, Tablet, 50 mg, NDC 00832030200, Pedigree: AD32973_4, EXP: 5/9/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC

Terminated Labeling / mix-up Aidapak Services, LLC D-466-2014
Class II · Moderate risk

Omega-3 Fatty Acid

Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, N

Terminated Labeling / mix-up Aidapak Services, LLC D-465-2014
Class II · Moderate risk

Calcium Carbonate +d3

Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014; or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-464-2014
Class II · Moderate risk

Zinc Gluconate

Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-463-2014
Class II · Moderate risk

Pyridostigmine Bromide Tablets 60 mg

Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.

Terminated Stability / shelf life Core Pharma Llc NDC 64720-128-10 D-1062-2013
Class II · Moderate risk

Selenium

Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD56917_13, EXP: 5/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1029-2014
Class II · Moderate risk

Niacin

Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD54516_1, EXP: 5/20/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W002920, EXP: 6/10/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1028-2014
Class II · Moderate risk

Niacin

Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W002660, EXP: 6/5/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1027-2014
Class II · Moderate risk

Tri-Buffered Aspirin

Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: W003596, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1026-2014
Class II · Moderate risk

Aspirin Ec

Labeling: Label Mixup: ASPIRIN EC, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg, NDC 58914001460, Pedigree: AD30180_10, EXP: 5/9/2014; DILTIAZEM HCL ER, Capsule, 240 mg, NDC 49884083109, Pedigree: AD52375_1, EXP: 5/17/2014; ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W003355, EXP: 6/19/2014; ASPIRIN, Tab

Terminated Labeling / mix-up Aidapak Services, LLC D-1025-2014
Class II · Moderate risk

Niacin Tr

Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 mg, NDC 00603506321, Pedigree: AD46265_49, EXP: 5/15/2014; MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD60240_14, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002693, EXP: 6/5/2014; GLUCOSAMIN

Terminated Labeling / mix-up Aidapak Services, LLC D-1024-2014
Class II · Moderate risk

Niacin Tr

Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: W003477, EXP: 6/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1023-2014

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