Vitruvias Therapeutics’ 30 mg thyroid tablet lot found potentially “superpotent”; FDA elevates recall to highest risk level as nearly 1,955 bottles have already been sold.
The U.S. Food and Drug Administration (FDA) has elevated a recall of a thyroid medication to its most serious category. The move comes after tests showed that certain tablets in a specific lot of Vitruvias Therapeutics Inc.’s 30 mg Thyroid Tablets, USP may be stronger than intended (superpotent).
Under FDA rules, a Class I recall means there is a reasonable probability that using the product could cause serious adverse health consequences or death.
Which lot and how much is affected
The affected product is “Thyroid Tablets, USP” 30 mg, lot number 504950, NDC 69680-166-00, with an expiration date of Sept. 30, 2026. The lot was distributed nationwide in the United States between Jan. 31 and Sept. 30, 2025.
According to the FDA recall notice, about 3,655 units were distributed and approximately 1,955 units have already been sold. Vitruvias Therapeutics had voluntarily recalled the lot earlier in the summer; the FDA has now upgraded that recall to Class I.
Why the recall and what are the risks
Testing indicated that some tablets in the lot could be superpotent. Taking such tablets could lead to symptoms of overactive thyroid (hyperthyroidism), including weight loss, heat intolerance, fatigue, high blood pressure, chest pain, rapid heartbeat, and irregular heart rhythm.usatoday+2
The FDA notes that older patients, pregnant women and children may face higher risks with long-term exposure. However, as of the late-August recall notice, the company had not received any reports of adverse events linked to this lot.
What patients should do
The FDA advises patients currently taking tablets from this lot not to stop medication abruptly. Instead, they should consult their healthcare provider for guidance on next steps, which may include switching to an alternative prescription or replacement.
For questions, consumers can contact Vitruvias Therapeutics via email at safety@vitruvias.com or by phone at 256-239-9373.
Context and recent pattern
This is not the only thyroid-related recall this year. In July, Major Pharmaceuticals voluntarily recalled certain configurations of its Levothyroxine Sodium Tablets after finding some were subpotent; that recall was classified as Class II. In the Vitruvias case, the concern is the opposite—tablets potentially being too strong—prompting the FDA’s Class I classification.
Separately, Vitruvias Therapeutics has indicated that it has ceased operations; its products are now owned and/or distributed by H2 Pharma LLC.
KEY FACTS:
FDA upgraded Vitruvias Therapeutics’ 30 mg thyroid tablet lot to a Class I recall due to potential superpotency.usatoday+2
Affected lot: 504950; NDC: 69680-166-00; expiry: Sept. 30, 2026; distributed: Jan. 31–Sept. 30, 2025.usatoday+1
About 3,655 units distributed; roughly 1,955 units sold; no adverse events reported as of the August notice.usatoday+1
SOURCES:
NewsNation — https://www.newsnationnow.com/health/fda-thyroid-tablet-recall-class-i/
Yahoo News — https://www.yahoo.com/news/us/articles/fda-upgrades-vitruvias-therapeutics-thyroid-142652156.html
