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.

Class II · Moderate risk

Niacin ER

Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000 units, NDC 53191036201, Pedigree: AD60268_4, EXP: 5/22/2014; METAXALONE, Tablet, 800 mg, NDC 64720032110, Pedigree: W003738, EXP: 6/26/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003716, EXP: 6/26/2014; C

Terminated Labeling / mix-up Aidapak Services, LLC D-808-2014
Class II · Moderate risk

Phenytoin Sodium ER

Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W003327, EXP: 6/19/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-807-2014
Class II · Moderate risk

Pregabalin

Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00781570192, Pedigree: AD21965_10, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD30180_25, EXP: 5/9/2014; clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00093083201, Pedigree: AD73518_1, EXP: 5/31/2014; OM

Terminated Labeling / mix-up Aidapak Services, LLC D-806-2014
Class II · Moderate risk

Pregabalin

Labeling: Label Mixup: PREGABALIN, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003713, EXP: 6/26/2014; glyBURIDE MICRONIZED, Tablet, 3 mg, NDC 00093803501, Pedigree: W003155, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-805-2014
Class II · Moderate risk

Sildenafil Citrate

Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, NDC 66213042510, Pedigree: W003640, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-804-2014
Class II · Moderate risk

Varenicline

Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-803-2014
Class II · Moderate risk

Phenol

Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-802-2014
Class II · Moderate risk

Efavirenz

Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: AD73637_1, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-801-2014
Class II · Moderate risk

Efavirenz

Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the following drug: metFORMIN HCl, Tablet 500 mg, NDC 23155010201, Pedigree: AD46312_25, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-800-2014
Class II · Moderate risk

MERCapsuleTOPURINE

Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 500 mg, NDC 00904052380, Pedigree: AD54576_4, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-799-2014
Class II · Moderate risk

Dexamethasone

Labeling: Label Mixup: DEXAMETHASONE, Tablet, 1 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL ER, Capsule, 150 mg, NDC 00093738656, Pedigree: AD30993_20, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-798-2014
Class II · Moderate risk

azaTHIOprine

Labeling: Label Mixup: azaTHIOprine, Tablet, 50 mg may have potentially been mislabeled as the following drug: SELENIUM, Tablet, 50 mcg, NDC 00904316260, Pedigree: AD56939_1, EXP: 5/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-797-2014
Class II · Moderate risk

Buprenorphine HCL Sl

Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-796-2014
Class II · Moderate risk

Acarbose

Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: AD60240_57, EXP: 5/22/2014; TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: W002724, EXP: 6/6/2014; SILDENAFIL CITRATE, Tablet, 25 mg, NDC 00069420030, Pedigree: W003646, EXP: 6/25/2014; SEVELAMER CARBONATE, Tab

Terminated Labeling / mix-up Aidapak Services, LLC D-795-2014
Class II · Moderate risk

Calcium Acetate

Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 64679071401, Pedigree: AD28355_1, EXP: 5/8/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: AD62865_1, EXP: 5/23/2014; ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: W003028, EXP: 6/12/2014; PROPRANO

Terminated Labeling / mix-up Aidapak Services, LLC D-794-2014
Class II · Moderate risk

Exemestane

Labeling: Label Mixup: EXEMESTANE, Tablet, 25 mg may be potentially mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003473, EXP: 6/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-793-2014
Class II · Moderate risk

Cilostazol

Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003469, EXP: 6/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-792-2014
Class II · Moderate risk

Lithium Carbonate ER

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD39588_10, EXP: 5/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-791-2014
Class II · Moderate risk

Lithium Carbonate ER

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6

Terminated Labeling / mix-up Aidapak Services, LLC D-790-2014
Class II · Moderate risk

Lithium Carbonate ER

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-789-2014
Class II · Moderate risk

Flecainide Acetate

Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, EXP: 5/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-788-2014
Class II · Moderate risk

Calcitriol

Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160, Pedigree: AD46414_7, EXP: 5/16/2014; BENAZEPRIL HCL, Tablet, 5 mg, NDC 65162075110, Pedigree: AD52778_7, EXP: 5/20/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003615, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-787-2014
Class II · Moderate risk

Progesterone

Labeling: Label Mixup: PROGESTERONE, Capsule, 100 mg may be potentially mislabeled as the following drug: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD46265_40, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-786-2014
Class II · Moderate risk

Pancrelipase Dr

Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD

Terminated Labeling / mix-up Aidapak Services, LLC D-785-2014
Class II · Moderate risk

Pancrelipase Dr

Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: AD70639_4, EXP: 7/28/2013.

Terminated Labeling / mix-up Aidapak Services, LLC D-784-2014

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