Thyroid Medication Recalled

More than 96,000 bottles of liothyronine sodium tablets were recalled by Sun Pharmaceutical Industries Inc. for failing to meet impurity/degradation specifications, according to the December 20, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes liothyronine sodium tablets, 5 mcg, in 100-count bottles (NDC 62756-589-88) from lots DND0059A (Exp. 12/23), DND0060A (Exp. 12/23), DND0061A (Exp. 12/23), DND0062A (Exp. 1/24), DND0063A (Exp. 1/24), DND0064A (Exp. 1/24), DND0065A (Exp. 1/24), DND0180A (Exp. 1/24), DND0181A (Exp. 1/24), DND0182A (Exp. 1/24), DND0183A (Exp. 1/24), DND0184A (Exp. 1/24), and DND0597A (Exp. 2/24).

The affected tablets were manufactured by Sun Pharmaceutical Industries Ltd., Dadra, India, and distributed by Sun Pharmaceutical Industries, Cranbury, New Jersey, throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall December 4, 2023. The FDA designated the recall Class II on December 14, 2023. Per the recall classification, use of the tablets may cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Liothyronine is a prescription medication used in the treatment of hypothyroidism and thyroid cancer.