FDA recalls Vitruvias thyroid tablets after testing finds potential ‘superpotency’; here’s who faces greater risk

The US Food and Drug Administration (FDA) has announced a nationwide recall of one lot of Vitruvias Therapeutics Inc.'s Thyroid Tablets, USP, 30 mg, after testing confirmed the product may be “superpotent.”

The recall involves Lot No. 504950, which was distributed across the United States. The FDA published the company's recall announcement on Monday, August 24, 2026, after Vitruvias Therapeutics initiated the voluntary recall on August 21.

Vitruvias Therapeutics thyroid tablets recalled

The recalled product is a natural thyroid preparation derived from porcine thyroid glands. It contains levothyroxine and liothyronine and is used to treat hypothyroidism, or an underactive thyroid.

According to the FDA recall notice, the affected product is:

• Product: Thyroid Tablets, USP 30 mg
• NDC: 69680-166-00
• Lot: 504950
• Expiration date: September 30, 2026
• Units released: 3,655
• Units sold: 1,955

Lot 504950 was distributed nationwide through Vitruvias Therapeutics' direct accounts between January 31, 2025, and September 30, 2025. The company said it is notifying wholesalers by email and phone and arranging for the destruction of recalled products.

Why was the thyroid medication recalled?

The recall was initiated because testing confirmed that the thyroid tablets could contain excessive levels of thyroid hormone, making them superpotent.

The FDA warns that taking superpotent thyroid tablets can lead to hyperthyroidism, a condition in which the body has excessive thyroid hormone.

Potential symptoms include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heartbeat and heart rhythm disturbances.

The FDA's recall notice states that certain groups face a greater risk from superpotent thyroid medication, particularly older adults, pregnant women and infants, especially when exposure occurs over an extended period.

Excess thyroid hormone in older adults has been associated with adverse outcomes, particularly involving heart health. In pregnancy, overtreatment of hypothyroidism has been associated with increased maternal and fetal complications, including premature delivery and low birth weight. In infants, overtreatment may negatively affect growth and development.

Patients should not stop taking the recalled medication on their own

Despite the recall, patients taking the affected Vitruvias Therapeutics thyroid tablets are being advised not to discontinue treatment without first contacting their healthcare provider. According to the FDA notice, patients currently taking Thyroid, USP from Lot 504950 should contact their healthcare provider for guidance and/or a replacement prescription.

Vitruvias Therapeutics said it has not received any reports of adverse events related to the recall so far. Consumers who have experienced problems that may be associated with the recalled medication should contact their physician or healthcare provider.

How to identify the recalled Vitruvias thyroid tablets

Patients who have Thyroid Tablets, USP 30 mg at home should check the packaging for Lot No. 504950 and the product's identifying information. Adverse reactions or quality problems involving the product can be reported through the FDA's MedWatch Adverse Event Reporting program.