A thyroid medicine recall is drawing attention after the US Food and Drug Administration gave the affected product its most serious recall classification.
The recall involves one lot of Thyroid Tablets, USP 30 mg, which is sold by Vitruvias Therapeutics. The company voluntarily had recalled the tablets in August after testing found they could be “superpotent,” which means that they may contain more thyroid hormone than intended. Then the FDA classified the recall as Class I on September 22.
What Is the Thyroid Tablet Recall About
The recall is limited to one lot of Vitruvias Therapeutics’ Thyroid Tablets, USP 30 mg and the FDA identified the affected lot as Lot No 504950, with an NDC number of 69680-166-00 and an expiration date of September 30, 2026.
According to the FDA, 3,655 units from the lot were released and 1,955 were sold. The affected tablets were distributed nationwide in the United States between January 31 and September 30, 2025.
The issue came to light after testing showed the potential for the tablets to be superpotent.
Why Did the FDA Give the Recall a Class I Rating
The FDA classified the recall as Class I on September 22.
USA TODAY reported that the Class I designation is the FDA’s highest recall classification. The FDA uses this category when there is a reasonable probability that using or being exposed to a recalled product could cause serious health consequences or death.
Vitruvias Therapeutics initiated the voluntary recall, then the FDA later assigned the Class I classification to the recall.
What Is the Risk With the Recalled Thyroid Tablets
The worry is that the tablets containing high levels of thyroid hormones may lead to hyperthyroidism, as per the FDA.
The agency lists possible effects including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, a rapid heart rate and heart rhythm disturbances.
According to the FDA, the risks to the elderly, pregnant women, and children are higher, especially with long-term use of highly potent thyroid tablets.
Which Thyroid Medicine Is Being Recalled
The recall applies specifically to Thyroid Tablets, USP 30 mg from Lot No 504950.
Consumers must check the product information for:
Product: Thyroid Tablets, USP 30 mg
NDC: 69680-166-00
Lot number: 504950
Expiration date: September 30, 2026
The FDA says the affected lot was distributed nationwide to Vitruvias Therapeutics’ direct accounts.
What Should People Taking the Recalled Tablets Do
The FDA advises patients taking Thyroid, USP from the affected lot not to stop taking the medicine on their own.
Instead, patients should contact their healthcare provider for guidance or a replacement prescription, the FDA says.
Consumers who experience problems that they believe may be related to the recalled product should also contact their physician or healthcare provider.
Were Any Adverse Events Reported
At the time of the recall announcement, Vitruvias Therapeutics had not received reports of adverse events known to be related to the recall, as per the FDA.
The company was also notifying wholesalers to stop distributing the affected product and arranging for the recalled tablets to be destroyed.
Why Is the Recall Getting Attention Now
The recall itself began in August when Vitruvias Therapeutics voluntarily recalled the affected lot after testing raised concerns about its potency.
The FDA’s September 22 Class I classification has brought renewed attention to the recall because it places the affected lot in the agency’s most serious recall category.
For consumers, the key detail is the lot number, the recall applies specifically to Lot No. 504950 of Thyroid Tablets, USP 30 mg, rather than all thyroid tablets or all products made by the company.
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