The Food and Drug Administration has issued a nationwide recall on levothyroxine sodium tablets due to subpotent drug levels.
The Food and Drug Administration has initiated a nationwide recall of levothyroxine sodium tablets, a common medication used to treat hypothyroidism and enlarged thyroid glands. The recall, classified as a Class II, was prompted by the discovery that the tablets are "subpotent," meaning they contain less of the active ingredient than prescribed. This may result in patients being under-treated, potentially allowing symptoms such as fatigue and weight gain to persist. Major Pharmaceuticals, based in Dublin, Ohio, voluntarily issued the recall on July 13. The affected products were distributed nationwide by Major Pharmaceuticals and Cardinal Health. Patients are advised to check the lot numbers on their medication packaging and contact their pharmacy for a refund or replacement. Because the recall is Class II, the administration noted that while the medication may cause temporary or medically reversible adverse health consequences, the probability of serious harm is remote. Patients experiencing health concerns after taking the recalled medication should seek medical attention.