A nationwide recall of Vitruvias Therapeutics thyroid tablets has been upgraded to the US Food and Drug Administration’s highest risk category after tests found the medicine could be stronger than intended.
The Class I designation means there is a reasonable probability that using or being exposed to the affected product could cause serious adverse health consequences or death, according to the FDA.
The recall affects one lot of Thyroid Tablets, USP 30mg, manufactured by Vitruvias Therapeutics. The company began the voluntary recall in August after testing confirmed the potential for the tablets to be “superpotent”.
Which thyroid tablets are affected?
Patients should check for lot number 504950 and the National Drug Code 69680-166-00. The tablets have an expiry date of 30 September 2026.
The FDA said 3,655 units were released, with 1,955 sold, after being distributed to Vitruvias Therapeutics’ direct accounts across the US between 31 January and 30 September 2025.
Thyroid, USP is used to treat hypothyroidism, or an underactive thyroid. The medicine is a natural preparation derived from porcine thyroid glands and contains levothyroxine and liothyronine.
Taking tablets that are more potent than intended can cause hyperthyroidism, or an overactive thyroid. Possible symptoms include weight loss, heat intolerance, tiredness, nervousness, muscle weakness, high blood pressure, chest pain, a rapid heartbeat and disturbances to the heart’s rhythm.
Older people, pregnant women and infants face a greater risk of harm. Excess thyroid hormones in older patients can particularly affect heart health, while overtreatment during pregnancy has been associated with complications including premature delivery and low birth weight.
Vitruvias Therapeutics said it had not received any reports of adverse events known to be linked to the recalled tablets as of 24 August.
Patients taking the affected product should not stop without first speaking to their doctor or other healthcare provider. They may need alternative treatment or a replacement prescription.
Anyone who believes they have suffered an adverse effect should contact a healthcare professional and report it through the FDA’s MedWatch programme. Vitruvias is notifying wholesalers to stop distributing the tablets and is arranging for the recalled stock to be destroyed.
