The U.S. Food and Drug Administration (FDA) recently announced the voluntary recall of levothyroxine sodium tablets initiated by Major Pharmaceuticals and Cardinal Health. The July 17 recall was classified as a Class II recall. The stated reason for the recall was that the affected tablets were found to be subpotent.

Click here to view the full FDA recall alert.

Levothyroxine is indicated in adult and pediatric patients for hypothyroidism (as replacement therapy in primary [thyroidal], secondary [pituitary], and tertiary [hypothalamic] congenital or acquired hypothyroidism) and pituitary thyrotropin suppression (as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer).

Related Clinical Practice Guidelines
  • Hypothyroidism in Adults
    • American Association of Clinical Endocrinologists (AACE), American Thyroid Association (ATA)
    • December 2012

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