Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

943 recalls · Class II, newest first

Class II · Moderate risk

Amantadine HCL

Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: AD52993_4, EXP: 5/17/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 65862048901, Pedigree: AD49582_22, EXP: 4/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1013-2014
Class II · Moderate risk

Losartan Potassium

Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as the following drug: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 60505267109, Pedigree: AD21965_4, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1012-2014
Class II · Moderate risk

Bromocriptine Mesylate

Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD32582_3, EXP: 5/9/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1011-2014
Class II · Moderate risk

Levothyroxine Sodium

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD21846_1, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1010-2014
Class II · Moderate risk

Levothyroxine Sodium

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD46265_1, EXP: 5/15/2014; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg, NDC 63304029601, Pedigree: AD70629_10, EXP: 5/29/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 76439030910, Pedigree: W003438, EXP:

Terminated Labeling / mix-up Aidapak Services, LLC D-1009-2014
Class II · Moderate risk

methylPREDNISolone

Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD52778_37, EXP: 5/20/2014; NABUMETONE, Tablet, 500 mg, NDC 00185014501, Pedigree: AD46426_4, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD54586_10, EXP: 5/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1008-2014
Class II · Moderate risk

Tacrolimus

Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014; ATOMOXE

Terminated Labeling / mix-up Aidapak Services, LLC D-1007-2014
Class II · Moderate risk

Tacrolimus

Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, EXP: 6/18/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1006-2014
Class II · Moderate risk

Mycophenolate Mofetil

Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: W003213, EXP: 6/14/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011010, Pedigree: AD65317_1, EXP: 5/24/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1005-2014
Class II · Moderate risk

Terazosin HCL

Labeling: Label Mixup: TERAZOSIN HCL, Capsule, 5 mg may have potentially been mislabeled as the following drug: DOXAZOSIN MESYLATE, Tablet, 1 mg, NDC 00093812001, Pedigree: W003912, EXP: 6/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1004-2014
Class II · Moderate risk

Amantadine HCL

Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W002725, EXP: 6/6/2014; clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: W002998, EXP: 6/11/2014; ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: W003672, EXP: 2/28/2014; NIACIN TR, Capsule, 500 mg, N

Terminated Labeling / mix-up Aidapak Services, LLC D-1003-2014
Class II · Moderate risk

Imipramine HCL

Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110, Pedigree: AD49448_7, EXP: 5/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1002-2014
Class II · Moderate risk

Isosorbide Dinitrate

Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1001-2014
Class II · Moderate risk

Isosorbide Dinitrate

Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1000-2014
Class II · Moderate risk

Zolpidem Tartrate Tablets 5 mg

Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.

Terminated Labeling / mix-up American Health Packaging NDC 68084-225-01 D-856-2013
Class II · Moderate risk

Pure-Aid Allergy Relief

Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine

Terminated Labeling / mix-up Kareway Product Inc D-620-2013
Class II · Moderate risk

Ropinirole hydrochloride tablets

Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..

Terminated Labeling / mix-up Mylan Pharmaceuticals Inc. NDC 0378-5504-01 D-500-2013
Class II · Moderate risk

Walmart Amlodipine Besylate Tablets

Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.

Terminated Labeling / mix-up Legacy Pharmaceutical Packaging LLC NDC 68645-445-70 D-319-2013
Class II · Moderate risk

Pentrexcilina Jarabe NF

Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.

Terminated Labeling / mix-up Opmx, LLC D-300-2013
Class II · Moderate risk

Pentrexcilina

Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.

Terminated Labeling / mix-up Opmx, LLC D-299-2013
Class II · Moderate risk

Children's Acetaminophen Oral Suspension

Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

Terminated Labeling / mix-up Precision Dose Inc. NDC 68094-650-59 D-250-2013
Class II · Moderate risk

Donnatal Extentabs

Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.

Terminated Labeling / mix-up West-ward Pharmaceutical Corp. NDC 66213-421-10 D-306-2013
Class II · Moderate risk

FREPP/SEPP Kit containing 1 FREPP

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Terminated Labeling / mix-up CareFusion 213, LLC NDC 54365-202-99 D-229-2013

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