A thyroid medicine recall in the United States has been upgraded to the highest-risk category after further testing raised safety concerns. The U.S. Food and Drug Administration (FDA) upgraded the recall of Vitruvias Therapeutics’ 30mg thyroid tablets to Class I.
The recall involves one lot of Thyroid Tablets, USP, identified by lot number 504950. The product carries National Drug Code 69680-166-00.
The voluntary recall began last month and covers tablets with an expiration date of September 30, 2026. The affected products were distributed nationwide between January 31 and September 30, 2025.
Why Did the FDA Upgrade the Recall?
Further testing found that the affected thyroid tablets could be superpotent. This means the tablets may contain a stronger dose than intended.
According to the FDA, taking superpotent thyroid medicine can cause an overactive thyroid. The condition can lead to several health problems and symptoms.
These may include weight loss, heat intolerance, fatigue, high blood pressure, chest pain and rapid heartbeat. It can also cause heart rhythm problems.
The FDA considers elderly patients, pregnant women and infants to face the highest risk. The risk is particularly concerning with prolonged use.
How Many Thyroid Tablets Were Distributed?
The affected lot was distributed across the United States during the specified period. The recall covers 3,655 units of the product.
Of those units, around 1,955 were sold. The remaining units were included within the recalled lot.
The product involved in the recall is identified by lot number 504950. Its National Drug Code is 69680-166-00.
What Does a Class I Recall Mean?
The FDA’s Class I designation represents its highest-risk recall category. It applies when there is a reasonable probability that exposure could cause serious adverse health effects or death.
In this case, the classification follows testing that found the tablets could be stronger than intended. Therefore, the FDA has placed the affected lot under its highest-risk recall category.
Company Reports No Adverse Events
Vitruvias Therapeutics said it had received no reports of adverse events linked to the affected lot. The company made the statement when the recall notice was published on August 24.
The company has also recently announced that it has ceased operations. Its products are now owned or distributed by H2-Pharma LLC.
The recall concerns the specific lot identified by the FDA. Consumers and healthcare providers should therefore pay close attention to the lot number and product details when checking the affected tablets.
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