Voluntary Recall Announced for Levothyroxine Sodium Oral Solution for Hypothyroidism

The FDA announced that pharmaceutical company IBSA Pharma recalled 27 lots of levothyroxine sodium (TIROSINT-SOL) oral solution due to sub-potency.¹

According to FDA officials, IBSA Pharma’s analysis indicated a decrease below 95.0% of its labeled amount in levothyroxine sodium in some samples.

In addition to hypothyroidism, the solution can also be used for pituitary thyrotropin suppression for inclusion in the treatment of thyrotropin-dependent, well-differentiated thyroid cancer.

The announcement also noted that either over or undertreatment with the solution may result in negative side effects on such things as cardiovascular function, growth, development, reproductive function, cognitive function, gastrointestinal function, and glucose/lipid metabolism.

“Patients being treated for hypothyroidism…who receive subpotent (levothyroxine sodium oral solution) may experience signs and symptoms of hypothyroidism which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight,” the FDA officials wrote.

However, the announcement also noted that the company has yet to learn about any adverse events resulting from the product’s recall.

The FDA officials recommended that if any of those using the solution have experienced issues—especially if they are pregnant, are elderly, or have newborn infants—they should contact their clinician or health provider.

They added that patients prescribed the solution are advised not to discontinue use before first consulting with their clinician or health provider.

References:

1. FDA MedWatch - select lots of TIROSINT-sol (levothyroxine sodium) oral solution by IBSA Pharma. U.S. Food and Drug Administration. https://content.govdelivery.com/accounts/USFDA/bulletins/3465905. Published February 2, 2023. Accessed February 2, 2023.