Thyroid medication recall upgraded to FDA's highest risk level

By
FOX Local
Published September 24, 2026 2:52 PM CDT

Vitruvias Therapeutics, Inc., issued a recall on a single lot of its Thyroid Tablets. (FDA)

The Brief

    • A thyroid medication that was recalled last month because it’s potentially "superpotent" has been upgraded to the Food and Drug Administration’s highest risk level. 
    • The Thyroid, USP tablets were manufactured by Vitruvias Therapeutics and initially recalled on Aug. 24. 
    • The FDA describes a Class I recall as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

A thyroid medication recall announced last month has been upgraded to the highest risk level allotted by federal regulators, according to the Food and Drug Administration. 

Vitruvias Therapeutics Inc. voluntarily recalled one lot of its Thyroid Tablets, USP 30 mg, in late August because "testing confirmed the potential for the product to be superpotent." On Tuesday, the recall was upgraded to Class I, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Thyroid medication recalled

By the numbers:

The lot number for the recalled thyroid tablets is 504950. About 3,655 units were distributed nationwide to Vitruvias Therapeutics' direct accounts from Jan. 31, 2025 to Sept. 30, 2025. The expiration date for the recalled tablets is Sept. 30, 2026. 

According to the FDA, Thyroid, USP is used to treat hypothyroidism, or an underactive thyroid.

RELATED: More than 167,000 pounds of beef, pork, and goat meat recalled

Dig deeper:

Overpotent thyroid tablets can cause an overactive thyroid, which could lead to symptoms like: 

  • Weight loss
  • Heat intolerance
  • Fatigue
  • Nervousness
  • Muscle weakness
  • Hypertension
  • Chest pain
  • Rapid heart rate
  • Heart rhythm disturbances

Elderly people, pregnant women and infants are at greater risk of harm from an overactive thyroid, the FDA says. 

As of Aug. 24, there had been no reports of injuries or deaths linked to the recalled tablets. 

What you can do:

Patients who are currently taking the recalled tablets should not stop taking them without contacting their healthcare provider for other guidance or a replacement prescription, Vitruvias said. 

If you experience any adverse health effects after taking the medication, contact your health care provider and report to the FDA’s MedWatch Adverse Event Reporting program. Vitruvias is reaching out to wholesalers to make sure the recalled tablets are destroyed. 

The Source: This article includes information from the U.S. Food and Drug Administration and previous FOX Local reporting.

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