US levothyroxine tablet recall

In late July 2026, the U.S. Food and Drug Administration announced a nationwide Class II recall of levothyroxine sodium tablets supplied by Major Pharmaceuticals after testing revealed the tablets were subpotent, delivering less hormone than indicated on the label. The initial notice on July 24 listed the affected dosage strengths (25 µg to 150 µg), packaging formats, lot numbers and expiration dates, and classified the recall as low‑risk because any health effects were expected to be temporary and reversible.

A follow‑up statement on July 27 reiterated the scope of the recall, covering 12 product lines across seven dosage strengths distributed from Indianapolis and through Cardinal Health. Patients were urged not to discontinue the medication without medical guidance and to verify the National Drug Code and lot numbers on their blister packs against the FDA list. The agency emphasized that while serious harm was unlikely, subpotent dosing could exacerbate hypothyroid symptoms such as fatigue, weight gain, cold intolerance and brain fog, and advised contact with pharmacists or physicians for replacement therapy.