Recall Issued for Multiple Lots of Levothyroxine Sodium Tablets Due to Subpotency

The US Food and Drug Administration (FDA) has issued a Class II recall for multiple strengths of Levothyroxine Sodium Tablets, USP, including 25 mcg, 50 mcg, 88 mcg, and 112 mcg doses. The recall, initiated on April 10, 2025, involves over 33 500 bottles distributed nationwide and was prompted by findings of subpotency—a condition in which the drug fails to meet labeled potency specifications. The affected products were manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare, Inc., based in Raleigh, North Carolina.

All affected lots—D2300323, D2400547, D2300044, and D2400725—are labeled with expiration dates ranging from December 2025 to March 2026. The FDA classified the recall as Class II on April 30, 2025, meaning that use of the subpotent product may cause temporary or medically reversible adverse effects, with a low likelihood of serious harm. Accord Healthcare notified customers by letter, and while no press release was issued, pharmacists are urged to review inventory and remove affected lots immediately to prevent compromised patient therapy.

Levothyroxine is a thyroid hormone replacement therapy indicated for the treatment of hypothyroidism, as well as for the suppression of thyroid-stimulating hormone (TSH) in conditions such as goiter or thyroid cancer. Subpotent levothyroxine may lead to inadequate thyroid hormone levels, causing symptoms like fatigue, weight gain, and cognitive impairment, particularly dangerous in elderly patients or those with cardiac conditions.