The U.S. Food and Drug Administration (FDA) has issued a nationwide recall for certain lots of levothyroxine sodium tablets, a medication commonly prescribed to treat hypothyroidism (underactive thyroid), enlarged thyroid glands (goiter), and a type of thyroid cancer. The recall was initiated on July 13, 2026, and classified as Class II on July 17, meaning the affected products "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".

The recall involves 12 different package configurations of levothyroxine sodium tablets in dosages ranging from 25 mcg to 150 mcg. The tablets were packaged and distributed by Major Pharmaceuticals, with Cardinal Health handling some distribution. They were sold nationwide in 10-count blister packs, sold individually or in cartons of 10 packs (100 tablets total), with expiration dates ranging from July 2026 through January 2027.

Why Was the Medication Recalled?

The FDA determined that the recalled levothyroxine sodium tablets are "subpotent," meaning they contain less of the active ingredient than indicated on the label. This could result in patients receiving a lower dose than their doctor prescribed, potentially compromising the effectiveness of their thyroid hormone replacement therapy.

The manufacturer, Major Rugby, stated in a letter to retailers that taking the recalled medication "is not likely to cause adverse health effects," but still urged consumers to return any affected products to the point of purchase. Patients are advised not to stop taking their medication without first consulting their healthcare provider, as abruptly discontinuing thyroid medication can lead to serious health consequences.

Which Products Are Affected?

The recall covers specific lot numbers and expiration dates of levothyroxine sodium tablets distributed under the Major and Cardinal brand names nationwide beginning in January 2025. Below is the complete list of affected products:

Source: FDA recall notice and manufacturer's letter to retailers

What Patients Should Do

If you take levothyroxine sodium tablets, follow these steps:

1. Check your prescription bottle – Compare the lot number and expiration date on your medication package against the list above.

2. Do not stop taking your medication – Suddenly discontinuing thyroid medication can cause serious health problems. Contact your doctor or pharmacist before making any changes to your treatment.

3. Return affected products – If your medication is included in the recall, return it to the pharmacy where it was purchased for a refund or replacement.

4. Monitor for symptoms – If you experience any health concerns after taking the recalled medication, seek medical attention immediately.

5. Contact the FDA – For questions about the recall, call 1-888-INFO-FDA (1-888-463-6332).

About Levothyroxine Sodium

Levothyroxine sodium is a synthetic thyroid hormone used to replace or supplement the natural thyroid hormone in patients with underactive thyroid glands. It is one of the most commonly prescribed medications in the United States, with more than 22 million prescriptions written annually. The medication is critical for regulating metabolism, energy levels, and overall bodily functions.