Major Pharmaceuticals has voluntarily recalled several batches of its levothyroxine sodium tablets across the United States after testing found that some lots contained lower-than-required levels of the active ingredient.
The recall, initiated on 13 July, affects multiple strengths of the prescription thyroid medication, including 25 mcg, 50 mcg, 75 mcg, 88 mcg, 112 mcg, 125 mcg and 150 mcg tablets.
The U.S. Food and Drug Administration (FDA) has classified the action as a Class II recall, indicating that use of the affected products could cause temporary or medically reversible adverse health effects, although the risk of serious health consequences is considered low.
Recalled Tablets May Be Less Effective
Levothyroxine is commonly prescribed to treat hypothyroidism and other thyroid disorders by replacing or supplementing thyroid hormone levels in the body.
According to the recall notice, some affected batches may be subpotent, meaning they contain less active ingredient than required. As a result, patients may not receive the intended dose, potentially leading to reduced treatment effectiveness.
People taking the affected medication could experience a return or worsening of symptoms associated with low thyroid hormone levels, including:
- Fatigue
- Weight gain
- Increased sensitivity to cold
- Difficulty concentrating
- Slower metabolism
Patients Advised Not to Stop Treatment Abruptly
Health experts recommend that patients do not stop taking levothyroxine without medical advice, as abruptly discontinuing thyroid hormone replacement therapy could worsen their condition.
Instead, patients should check the lot number printed on their medication packaging to determine whether their tablets are included in the recall. Anyone with an affected product should contact their doctor or pharmacist for guidance on replacement medication and continued treatment.
Major Pharmaceuticals has instructed customers to return recalled products to the pharmacy or retailer where they were purchased.
The company has not reported widespread injuries linked to the affected batches, but the recall is intended to prevent potential health risks associated with reduced medication potency.
