Lupin Pharmaceuticals has recalled seven strengths of levothyroxine sodium tablets after testing revealed the medication was less potent than expected.

The FDA classified a nationwide recall of levothyroxine sodium tablets as Class II on July 17, 2025, following reports that the medication was subpotent. Manufactured by Lupin Pharmaceuticals, Inc. and distributed by Major Pharmaceuticals and Cardinal Health, the affected tablets may contain a lower dose than indicated on the packaging. The recall impacts seven strengths of the medication, ranging from 25 to 150 micrograms.

Understanding the Recall

A Class II recall is a medium-risk designation indicating that exposure to the product may cause temporary or reversible health consequences, with a low probability of serious harm. The FDA and the manufacturer state that the use of the product is unlikely to cause adverse health effects. The recall is limited to the retail level, meaning pharmacies and health systems are required to pull the products from their shelves but are not mandated to notify individual patients.

Guidance for Patients

Patients are encouraged to continue taking their medication, as stopping treatment can sometimes cause more harm than continuing with a subpotent dose. Because pharmacies often dispense tablets into their own vials, the recall information may not appear on a patient's bottle. Individuals concerned about their dosage are advised to contact their pharmacy to verify the manufacturer, NDC number, and lot number of their prescription, or consult a doctor about checking thyroid hormone levels via a blood test.