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 Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count…

Reason Chemical contamination: emission of strong odor after package was opened.

Pfizer Inc. NDC 60793-857-01 D-258-2013

Class II · Moderate risk Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count…

Reason Chemical contamination: emission of strong odor after package was opened

Pfizer Inc. NDC 60793-856-01 D-257-2013

Class II · Moderate risk Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count…

Reason Chemical contamination: emission of strong odor after package was opened.

Pfizer Inc. NDC 60793-855-01 D-256-2013

Class II · Moderate risk Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count…

Reason Chemical contamination: emission of strong odor after package was opened..

Pfizer Inc. NDC 60793-854-01 D-255-2013

Class II · Moderate risk Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles…

Reason Chemical contamination: emission of strong odor after package was opened..

Pfizer Inc. NDC 60793-853-01 D-254-2013

Class II · Moderate risk Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count…

Reason Chemical contamination: emission of strong odor after package was opened.

Pfizer Inc. NDC 60793-852-01 D-253-2013

Class II · Moderate risk Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles…

Reason Chemical contamination: emission of strong odor after package was opened.

Pfizer Inc. NDC 60793-851-01 D-252-2013

Class II · Moderate risk Completed Mar 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles…

Reason Chemical contamination: emission of strong odor after package was opened..

Pfizer Inc. NDC 60793-850-01 D-251-2013

Class III · Low risk Terminated Mar 12, 2013

Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN…

Reason Failed Impurities/Degradation Specifications: 3 month stability testing.

L. Perrigo Co. NDC 0574-0220-01 D-318-2013

Class II · Moderate risk Terminated Dec 4, 2012

Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT…

Reason Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.

Abbott Laboratories NDC 0074-7069-90 D-107-2013

Class II · Moderate risk Terminated Nov 15, 2012

Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total…

Reason Subpotent; 15 month stability (by mfr)

Physicians Total Care, Inc. NDC 54868-4507-00 D-214-2013

Class II · Moderate risk Terminated Oct 29, 2012

Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical…

Reason Subpotent; 15 month stability

Alara Pharmaceutical Co D-104-2013

Class II · Moderate risk Terminated Jul 25, 2012

Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest…

Reason Subpotent; 9-month stability interval

Lloyd Inc. of Iowa NDC 0456-1322-01 D-103-2013

Class II · Moderate risk Terminated Jul 25, 2012

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest…

Reason Subpotent; 9-month stability interval

Lloyd Inc. of Iowa NDC 0456-1321-01 D-101-2013

Class II · Moderate risk Terminated Jul 19, 2012

Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064…

Reason Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the…

Abbott Laboratories D-1696-2012

Class II · Moderate risk Terminated Jul 19, 2012

Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064…

Reason Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the…

Abbott Laboratories D-1695-2012

Class II · Moderate risk Terminated Jul 19, 2012

Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064…

Reason Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the…

Abbott Laboratories D-1694-2012

Class II · Moderate risk Terminated Jul 9, 2012

Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest…

Reason cGMP Deviations; does not meet in process specification requirements

Lloyd Inc. of Iowa NDC 0456-1328-01 D-085-2013

Class II · Moderate risk Terminated Jul 9, 2012

Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest…

Reason cGMP Deviations; does not meet in process specification requirements

Lloyd Inc. of Iowa NDC 0456-1331-01 D-083-2013

Class II · Moderate risk Terminated Jul 9, 2012

Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest…

Reason cGMP Deviations; does not meet in process specification requirements

Lloyd Inc. of Iowa NDC 0456-1324-01 D-081-2013

Class II · Moderate risk Terminated Jul 9, 2012

Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest…

Reason cGMP Deviations; does not meet in process specification requirements

Lloyd Inc. of Iowa NDC 0456-1330-01 D-079-2013

Class II · Moderate risk Terminated Jul 9, 2012

Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest…

Reason cGMP Deviations; does not meet in process specification requirements

Lloyd Inc. of Iowa NDC 0456-1329-01 D-077-2013

Class II · Moderate risk Terminated Jul 9, 2012

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest…

Reason cGMP Deviations; does not meet in process specification requirements

Lloyd Inc. of Iowa NDC 0456-1321-01 D-075-2013

Class II · Moderate risk Terminated May 21, 2012

LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 ML (1 PRODUCT)

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1557-2012

Class II · Moderate risk Terminated Feb 24, 2012

Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest…

Reason Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.

Lloyd Inc NDC 0456-1322-01 D-1394-2012

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