Vitruvias Therapeutics is recalling one lot of Thyroid Tablets, USP 30 mg because testing found the medication may be stronger than intended.
Excess thyroid hormone can cause chest pain, rapid heartbeat, high blood pressure, nervousness and other symptoms.
Patients should not stop taking the medication without first contacting a healthcare provider for guidance or a replacement prescription.
Vitruvias Therapeutics has issued a nationwide recall of one lot of prescription thyroid medication after testing confirmed that the tablets may be “superpotent,” meaning they could contain more active thyroid hormone than intended.
The recall covers Thyroid Tablets, USP 30 mg from lot number 504950. The product’s identifying information is:
NDC: 69680-166-00
Lot number: 504950
Expiration date: Sept. 30, 2026
The affected medication was distributed nationwide to the company’s direct accounts between Jan. 31 and Sept. 30, 2025, according to the recall notice posted by the Food and Drug Administration.
Thyroid Tablets, USP is a natural preparation made from porcine thyroid glands. It contains the thyroid hormones levothyroxine and liothyronine and is prescribed to treat hypothyroidism, commonly known as an underactive thyroid.
Why the medication may be dangerous
Taking thyroid medication that is stronger than labeled can expose patients to excessive levels of thyroid hormones and cause hyperthyroidism, or an overactive thyroid.
Possible symptoms include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heartbeat and abnormal heart rhythms.
The risks may be especially serious for older adults, pregnant women and infants, particularly when exposure continues over an extended period.
In older patients, excessive thyroid hormone levels have been linked to adverse cardiac outcomes. Overtreatment during pregnancy may increase the risk of premature delivery, low birth weight and other complications affecting the mother and fetus. In infants, too much thyroid hormone may negatively affect growth and development.
Vitruvias said it had not received any reports of adverse events associated with the recalled lot as of the recall announcement.
What patients should do
Patients should check their medication packaging for lot number 504950. Those who have the recalled tablets should contact their doctor or pharmacist for instructions and a possible replacement.
The company stressed that patients should not abruptly discontinue thyroid medication without first speaking with a healthcare provider. Suddenly stopping treatment could leave hypothyroidism untreated and create other health risks.
Vitruvias is notifying wholesalers by email and telephone, directing them to stop distributing the affected medication and arranging for recalled products to be destroyed.
Consumers with questions may contact Vitruvias Therapeutics at safety@vitruvias.com or 256-239-9373, Monday through Friday from 9 a.m. to 5 p.m. Central time.
Anyone who has experienced a health problem that may be connected to the medication should contact a healthcare provider. Adverse reactions and product-quality issues may also be reported through the FDA’s MedWatch program.