Major Pharmaceuticals has voluntarily recalled multiple strengths and lot numbers of levothyroxine sodium tablets nationwide. The recall, initiated July 13, affects a widely used thyroid medication and was prompted by concerns that the tablets are subpotent — meaning they may contain less active ingredient than required.
What is being recalled
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Twelve separate product lines are included in the recall, spanning seven dosage strengths — 25 mcg, 50 mcg, 75 mcg, 88 mcg, 112 mcg, 125 mcg and 150 mcg. All products are packaged in unit dose blister cartons and were packaged and distributed by Major Pharmaceuticals out of Indianapolis.
Why subpotency matters for thyroid patients
Levothyroxine sodium is a synthetic thyroid hormone commonly prescribed to treat hypothyroidism — a condition in which the thyroid gland does not produce enough hormone on its own. Because the medication works by directly replacing or supplementing natural thyroid hormone levels, even small reductions in potency can affect how well a patient’s condition is managed.
Subpotent thyroid medication could leave patients under-treated, potentially allowing hypothyroid symptoms — such as fatigue, weight gain, cold sensitivity and cognitive difficulties — to persist or worsen. Patients who believe they may have received affected product are encouraged to contact their healthcare provider.
What patients, pharmacists should do
The recall is ongoing and no press release has been issued by the firm. Notification to consignees and the public was made by letter. Patients who have questions about whether their prescription is affected should check the lot number on their medication packaging and consult their pharmacist or physician.
Healthcare providers and pharmacies that have distributed the affected lots should follow standard recall procedures and quarantine any remaining inventory.
About the recall classification
The FDA uses a tiered classification system for drug recalls. A Class I recall is the most serious, involving products that could cause serious injury or death. A Class II recall, as assigned here, applies to products where use may cause temporary or medically reversible adverse health consequences, but where the probability of serious harm is remote. A Class III recall involves products unlikely to cause any adverse health consequences.