FDA Classifies Thyroid Tablet Recall as Class I: Patients Urged to Check Lot Number

The U.S. Food and Drug Administration has placed a recalled thyroid medication in its highest risk category after testing found that tablets from one lot could contain more thyroid hormone than intended.

The recall involves Vitruvias Therapeutics Thyroid Tablets, USP 30 mg, a thyroid hormone replacement product derived from porcine, or pig, thyroid glands. The FDA classified the recall as Class I on Sept. 22, 2026, meaning the agency determined that use of the affected product could reasonably be expected to cause serious health consequences or death.

The original recall was announced by Vitruvias Therapeutics on Aug. 21, 2026, after testing confirmed the potential for the tablets to be "superpotent," or stronger than intended. The FDA published the company's recall announcement on Aug. 24.

Which Thyroid Tablets Are Included in the Recall?

The recall applies to one specific lot of Thyroid Tablets, USP 30 mg. Consumers should check the information printed on their medication packaging rather than assuming that every thyroid tablet made by the company is affected.

The recalled product details are:

• Product: Thyroid Tablets, USP 30 mg
• NDC: 69680-166-00
• Lot number: 504950
• Expiration date: Sept. 30, 2026
• Units sold: 1,955
• Distribution: Nationwide in the United States

According to the FDA, the affected lot was distributed through Vitruvias Therapeutics' direct accounts between Jan. 31, 2025, and Sept. 30, 2025. The company said 3,655 units were released, with 1,955 units sold.

Consumers who have the medication at home can compare the lot number and other identifying information on the bottle with the FDA recall information.

Why Were the Thyroid Tablets Recalled?

The main concern is potential superpotency.

Thyroid hormone medicines are intended to provide a specific amount of hormone to help replace hormones that the body does not produce adequately. If a tablet contains more thyroid hormone than intended, a patient could receive a higher dose than prescribed.

Vitruvias said taking superpotent thyroid tablets can lead to hyperthyroidism, a condition in which the body has excessive thyroid hormone activity.

Potential symptoms listed in the company's FDA-posted recall notice include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heartbeat and disturbances in heart rhythm.

The company specifically identified older adults, pregnant women and infants as groups that may face greater risks from excessive thyroid hormone exposure, particularly with prolonged use.

Excess thyroid hormone can be particularly concerning for the cardiovascular system in older adults. During pregnancy, excessive thyroid hormone treatment may also be associated with maternal and fetal complications, according to the recall notice. In infants, overtreatment may affect growth and development.

What Does an FDA Class I Recall Mean?

An FDA Class I recall is the agency's most serious recall classification.

The classification is used when there is a reasonable probability that exposure to or use of a recalled product could result in serious adverse health consequences or death. The classification describes the potential risk associated with the recalled product. It does not mean that every person who used the product will experience a serious health problem.

For the Vitruvias thyroid tablet recall, the Class I classification follows the company's August recall announcement concerning the potential for the affected tablets to be stronger than intended.

As of the company's August recall notice, Vitruvias said it had not received reports of adverse events known to be related to the recall.

What Should Patients Taking the Recalled Thyroid Medicine Do?

Patients who believe they are taking Thyroid Tablets, USP 30 mg from Lot 504950 should check their medication packaging and contact their healthcare provider or pharmacist.

Vitruvias specifically advised patients not to discontinue the recalled medication without first contacting their healthcare provider for further guidance or a replacement prescription.

This advice is important because thyroid hormone replacement is prescribed to manage an underlying medical condition. Stopping or changing a thyroid medication without professional guidance may create a separate health concern.

A healthcare professional can determine whether a patient has the recalled lot and advise on an appropriate replacement or treatment plan.

People who develop concerning symptoms after taking a recalled medication should seek medical attention. Symptoms such as chest pain, a rapid or irregular heartbeat, significant weakness or other severe symptoms may require prompt medical evaluation.

Vitruvias Thyroid Medication and Animal-Derived Thyroid Products

The recalled tablets are described by the FDA as a natural thyroid preparation derived from porcine thyroid glands. The preparation contains thyroid hormones including levothyroxine and liothyronine and is used to treat hypothyroidism, or an underactive thyroid.

The FDA has previously raised broader concerns about animal-derived thyroid medications.

In an August 2025 communication to companies involved in animal-derived thyroid products, the FDA said these medicines are made from dried and ground animal thyroid glands and can contain multiple biological compounds. The agency also raised concerns about the consistency of these products.

This broader regulatory discussion should not be confused with the current recall. The September 2026 Class I recall specifically concerns one lot of Vitruvias Thyroid Tablets, USP 30 mg, Lot 504950.

What Happened to the Recalled Products?

Following the August recall, Vitruvias said it was notifying wholesalers and instructing them to stop distributing the affected product. The company also said it was arranging for recalled products to be destroyed.

The company's current website states that Vitruvias has ceased operations and that H2-Pharma LLC now owns or distributes its products.

Consumers with questions about the recall should rely on current information from the FDA, their pharmacist or healthcare provider when determining what action to take.

The FDA's original recall notice listed Vitruvias consumer contact information as (256) 239-9373 and safety@vitruvias.com. The FDA also directs consumers to its MedWatch program for reporting suspected adverse reactions or product quality problems.

Key Facts About the Vitruvias Thyroid Recall

The most important information for consumers is the product identification.

Medication: Thyroid Tablets, USP 30 mg
Manufacturer: Vitruvias Therapeutics Inc.
NDC: 69680-166-00
Affected lot: 504950
Expiration date: Sept. 30, 2026
Recall reason: Potential superpotency
FDA classification: Class I
Distribution: Nationwide in the United States

The FDA's Class I designation makes it especially important for patients, pharmacies and healthcare providers to identify any remaining medication from the affected lot.

The Bottom Line

The FDA has classified the Vitruvias Therapeutics recall of one lot of Thyroid Tablets, USP 30 mg as Class I, the agency's most serious recall category. The affected tablets may be more potent than intended, potentially exposing patients to excessive thyroid hormone.

Patients should check their medication for Lot 504950 and compare the product information with the official FDA recall notice. Anyone who believes they have the affected medication should contact a healthcare professional before making changes to their treatment.

The recall applies to a specific lot, not automatically to all thyroid medications or all Vitruvias thyroid tablets. Patients should therefore verify the lot number and follow guidance from their healthcare provider, pharmacist and the FDA.

Medical Disclaimer: This article is provided for general informational and educational purposes only and is not medical advice, diagnosis or treatment. Medication decisions should be made with a qualified healthcare professional. Do not stop, change or replace a prescribed thyroid medication based solely on information in this article. For questions about the recalled product, contact your healthcare provider or pharmacist and consult the official FDA recall information.