US Drug Recall Register

Thyroid Medication Recalls

Recalls of levothyroxine and other thyroid hormone replacement drugs, often over sub-potency.

226 recalls in this category, newest first.

Class II · Moderate risk Terminated

Thyroid Porcine active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-928-2015
Class II · Moderate risk Terminated

Methimazole active pharmaceutical ingredient packaged in varying…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-782-2015
Class II · Moderate risk Terminated

Liothyronine Sodium

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-765-2015
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-761-2015
Class II · Moderate risk Terminated

Liothyronine Sodium Tablets

Reason Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.

SigmaPharm Laboratories LLC NDC 42794-018-02 D-1344-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium Tablets

Reason Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

Mylan Pharmaceuticals Inc. NDC 0378-1819-01 D-1084-2014
Class II · Moderate risk Terminated

Liothyronine Sodium

Reason Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 25 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00378181701, Pedigree: W003151, EXP: 6/13/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003000, EXP: 6/11/2014.

Aidapak Services, LLC D-957-2014
Class II · Moderate risk Terminated

Liothyronine Sodium

Reason Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 5 mcg may have potentially been mislabeled as one of the following drugs: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 00574022201, Pedigree: W003152, EXP: 4/30/2014.

Aidapak Services, LLC D-956-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD60272_70, EXP: 5/22/2014.

Aidapak Services, LLC D-924-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD46265_34, EXP: 5/15/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003008, EXP: 6/11/2014.

Aidapak Services, LLC D-923-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD60272_19, EXP: 5/22/2014.

Aidapak Services, LLC D-922-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: W003007, EXP: 6/12/2014.

Aidapak Services, LLC D-921-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg) may have potentially been mislabeled as one of the following drugs: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD30180_1, EXP: 5/8/2014; carBAMazepine ER, Capsule, 200 mg, NDC 66993040832, Pedigree: AD32764_14, EXP: 5/14/2014; CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 00378022201, Pedigree:

Aidapak Services, LLC D-920-2014
Class II · Moderate risk Terminated

Thyroid

Reason Labeling: Label Mixup: THYROID, Tablet, 60 mg may have potentially been mislabeled as the following drug: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: W002847, EXP: 6/7/2014.

Aidapak Services, LLC D-914-2014
Class II · Moderate risk Terminated

Thyroid

Reason Labeling: Label Mixup: THYROID, Tablet, 30 mg may have potentially been mislabeled as one of the following drugs: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, NDC 11523726503, Pedigree: AD70655_20, EXP: 5/29/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 37205098769, Pedigree: AD73623_7, EXP: 5/30/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W002697, EXP: 6/5/2014.

Aidapak Services, LLC D-913-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 1 mg, NDC 16714058701, Pedigree: W003150, EXP: 6/13/2014.

Aidapak Services, LLC D-899-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as one of the following drugs: ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), NDC 00904533260, Pedigree: AD57624_1, EXP: 5/9/2014; hydrALAZINE HCl, Tablet, 50 mg, NDC 50111032801, Pedigree: AD52778_28, EXP: 5/20/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003828, EXP: 6/

Aidapak Services, LLC D-898-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: AD73611_7, EXP: 5/30/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003022, EXP: 6/12/2014; ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: W003474, EXP: 6/20/2014; HYDROCORTISONE, Tabl

Aidapak Services, LLC D-897-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00536406001, Pedigree: AD22865_13, EXP: 5/2/2014.

Aidapak Services, LLC D-812-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014.

Aidapak Services, LLC D-811-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 125 mcg may have potentially been mislabeled as the following drug: MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD70615_1, EXP: 2/28/2014.

Aidapak Services, LLC D-810-2014
Class II · Moderate risk Terminated

Liothyronine Sodium

Reason Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46414_22, EXP: 5/16/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD68010_4, EXP: 5/28/2014.

Aidapak Services, LLC D-557-2014
Class II · Moderate risk Terminated

Liothyronine Sodium

Reason Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 5 mcg may be potentially mislabeled as HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 16729018201, Pedigree: AD46414_25, EXP: 5/16/2014.

Aidapak Services, LLC D-556-2014
Class II · Moderate risk Terminated

LEVOTHYROXINE/ LIOTHYRONINE Tablet

Reason Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.

Aidapak Services, LLC D-555-2014
Class II · Moderate risk Terminated

Levothyroxine Sodium

Reason 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.

Aidapak Services, LLC D-1010-2014