FDA Recalls Popular Thyroid Medication: Is Your Levothyroxine Affected?

Millions of Americans who take levothyroxine, one of the most commonly prescribed medications for hypothyroidism, are being urged to check their medicine bottles after the U.S. Food and Drug Administration (FDA) announced a nationwide Class II recall affecting certain lots of the drug.

The recall involves levothyroxine sodium tablets distributed by Major Pharmaceuticals after testing found that some products were subpotent, meaning they may contain less of the active ingredient than stated on the label.

According to the FDA, use of the affected product could cause temporary or medically reversible health consequences, while the risk of serious harm is considered low.

Levothyroxine is used to treat hypothyroidism, a condition in which the thyroid gland does not produce enough hormones. It is also prescribed for certain patients with goiter and some forms of thyroid cancer.

Which levothyroxine products are affected?

The recall applies only to specific lots of levothyroxine sodium tablets distributed by Major Pharmaceuticals. The affected strengths include:

• 25 mcg
• 50 mcg
• 75 mcg
• 88 mcg
• 112 mcg
• 125 mcg
• 150 mcg

The tablets were distributed in 100-count cartons as well as 10-tablet blister packs. Patients should check the manufacturer, dosage strength, lot number and expiration date on their medication packaging to determine whether their prescription is included in the recall.

What should patients do?

Health experts stress that patients should not stop taking levothyroxine without speaking to their healthcare provider.

Stopping thyroid hormone replacement abruptly can allow hypothyroidism symptoms to return and may lead to complications, particularly for people who rely on the medication for long-term hormone replacement.

Instead, patients should:

• Check whether their medication matches the recalled lots.
• Contact their pharmacist or healthcare provider if they believe their prescription is affected.
• Discuss obtaining a replacement medication if necessary.
• Continue taking the medication unless instructed otherwise by a healthcare professional.

What does “subpotent” mean?

A subpotent drug contains less active medication than it is supposed to. For levothyroxine users, this could mean the body receives insufficient thyroid hormone, potentially leading to symptoms such as fatigue, weight gain, feeling unusually cold, constipation, depression, dry skin and slowed heart rate.

Not everyone taking an affected lot will experience symptoms, but prolonged use of a subpotent medication could reduce treatment effectiveness.