Patients who take levothyroxine are being urged to check their prescriptions after the U.S. Food and Drug Administration (FDA) issued a nationwide recall notice involving certain Levothyroxine Sodium Tablets found to contain less active medication than labeled. The voluntary recall, initiated by Major Pharmaceuticals, affects specific lots distributed nationwide, with some products also distributed by Cardinal Health.
The FDA designated the action as a Class II recall after determining the tablets were subpotent, meaning they may not provide the full amount of thyroid hormone replacement intended with each dose. While the agency considers the risk of serious adverse health consequences to be low, patients taking affected tablets may not receive the prescribed amount of medication needed to adequately treat hypothyroidism.
Why the Levothyroxine Recall Matters
Levothyroxine is one of the most commonly prescribed medications used to treat hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone. It is also prescribed to suppress thyroid-stimulating hormone in some patients with thyroid cancer and to help reduce the size of enlarged thyroid glands, known as goiters.
According to the American Thyroid Association, approximately 20 million Americans have some form of thyroid disease, and about 12% of the U.S. population will develop a thyroid disorder during their lifetime. Many rely on daily levothyroxine therapy to maintain normal metabolism, heart function, body temperature, and energy levels.
The FDA said the recalled tablets were found to contain less active ingredient than required. Because levothyroxine has a narrow therapeutic index, even relatively small differences in potency can affect treatment. Taking a subpotent product over time may result in inadequate thyroid hormone replacement, allowing hypothyroidism symptoms to return or worsen.
Symptoms Patients Should Watch For
Most patients are unlikely to notice immediate effects after taking a single recalled tablet. However, continued use of a subpotent medication over several days or weeks may lead to declining thyroid hormone levels.
Symptoms of hypothyroidism may include:
- Fatigue
- Brain fog or difficulty concentrating
- Weight gain
- Increased sensitivity to cold
- Constipation
- Dry skin
- Depression or mood changes
- Slower heart rate
Patients who are pregnant, have cardiovascular disease, or are receiving thyroid hormone suppression therapy following thyroid cancer treatment may be especially vulnerable to changes in thyroid hormone levels.
Which Levothyroxine Prescriptions Are Affected?
The nationwide recall includes 12 Levothyroxine Sodium Tablet products packaged and distributed by Major Pharmaceuticals, with some products also distributed by Cardinal Health.
Affected products include multiple tablet strengths packaged in 10-count blister packs sold individually and in cartons. The FDA said the recalled products were distributed nationwide but did not specify how many tablets are included in the recall.
Patients should review the manufacturer, strength, lot number, and expiration date listed on their prescription bottle or blister packaging. The complete list of affected National Drug Code numbers, lot numbers, and expiration dates is available through the FDA recall notice.
What Patients Should Do
Patients should not stop taking levothyroxine without first consulting their healthcare provider.
Instead, check whether your levothyroxine prescription is included in the recall. Your pharmacist can verify whether your medication is part of an affected lot and determine whether an unaffected replacement is available.
Patients who discover they have a recalled product or who develop new or worsening symptoms should contact their prescribing healthcare provider. Depending on the individual’s health status, a replacement prescription, follow-up thyroid function testing, or other treatment adjustments may be recommended.
Understanding the FDA Recall
The FDA classifies recalls according to the potential risk posed to patients. A Class II recall means use of the product may cause temporary or medically reversible adverse health effects, or that the probability of serious adverse health consequences is considered remote.
Although the overall risk is considered low, maintaining consistent thyroid hormone levels is essential for many patients. Checking whether your levothyroxine prescription is included in the recall and following up with your pharmacist or healthcare provider can help ensure your treatment remains safe and effective.