Auburn, Alabama — A nationwide recall involving a thyroid medication has been upgraded to the FDA’s highest risk classification after testing found that one lot of the tablets could be more potent than intended.
Vitruvias Therapeutics Inc. originally announced the voluntary recall in August involving its Thyroid Tablets, USP 30 mg, after testing confirmed the potential for the product to be superpotent. The FDA has now classified the recall as Class I, the most serious category used by federal regulators when there is a reasonable probability that exposure to a recalled product could cause serious health consequences or death.
One Lot of Thyroid Medication Is Affected
The recall applies to Lot 504950 of Vitruvias Therapeutics’ Thyroid Tablets, USP 30 mg.
According to the FDA, approximately 3,655 units were released, with 1,955 units sold, and the recalled lot was distributed nationwide to the company’s direct accounts between Jan. 31, 2025, and Sept. 30, 2025.
The recalled tablets have an expiration date of Sept. 30, 2026.
Thyroid, USP is used to treat hypothyroidism, a condition in which the body does not produce enough thyroid hormone. The medication contains thyroid hormones including levothyroxine and liothyronine and is derived from porcine thyroid glands.
Patients who have the medication should check the lot number on their packaging rather than assuming that every 30 mg thyroid tablet is part of the recall.
Why Superpotent Tablets Can Be Dangerous
The concern is that tablets from the recalled lot could contain more thyroid hormone than intended.
Taking an excessive amount can cause hyperthyroidism, or an overactive thyroid. According to the FDA, possible symptoms include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate and heart rhythm disturbances.
The FDA says certain groups face greater risks from excessive thyroid hormone exposure.
Older adults, pregnant women and infants are considered particularly vulnerable. In older adults, excessive thyroid hormone levels can be associated with adverse cardiac outcomes. During pregnancy, overtreatment can increase the risk of complications affecting both the mother and fetus, while excessive thyroid hormone exposure in infants may affect growth and development.
No Related Adverse Events Reported So Far
Despite the recall’s upgraded classification, the company said it had not received reports of adverse events known to be related to the recalled product at the time of its announcement.
The Class I designation does not mean that every person who took a recalled tablet will experience serious harm. Rather, it reflects the FDA’s classification of the potential risk associated with exposure to the violative product. The agency defines Class I recalls as situations involving a reasonable probability of serious adverse health consequences or death.
Patients Should Not Stop Medication on Their Own
For people who may have the recalled lot at home, the company has specifically advised patients not to stop taking the medication without first contacting their healthcare provider.
Stopping thyroid medication suddenly without medical guidance may create its own health concerns, so patients should speak with their doctor or pharmacist about whether they need a replacement prescription or another course of treatment.
Anyone who believes they have experienced an adverse reaction potentially connected to the medication should contact their healthcare provider.
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Health problems or quality concerns involving the recalled product can also be reported through the FDA’s MedWatch Adverse Event Reporting program.
Wholesalers Are Being Asked to Destroy Recalled Tablets
Vitruvias Therapeutics said it is contacting wholesalers by email and phone to ensure distribution of the recalled lot stops and that remaining recalled products are destroyed.
The company is also providing a direct contact option for consumers who have questions about the recall.
For patients, the most important step is to check the lot number on their medication and contact a healthcare professional if it matches 504950.
The recall serves as a reminder that medication problems can involve specific lots rather than an entire product line, making it important for patients to check the exact information on their prescription bottles before making changes to their treatment.
Do you or someone in your family take thyroid medication? Check your prescription bottle and share this information with anyone who may need to know about the recall.
