Thyroid medication recall classified under FDA's most urgent level

Preview

WASHINGTON — A nationwide recall of thyroid medication has been elevated to the FDA’s Class I category, the agency’s highest-risk recall level, after testing found one lot could contain excessive hormone potency.

Recall Upgraded to Class I

The recall concerns Thyroid Tablets, USP 30 mg, manufactured by Vitruvias Therapeutics. The company voluntarily recalled one lot after testing confirmed the potential for the tablets to be superpotent.

FDA posted the original company announcement in August, but the recall was classified as Class I on September 23. Class I indicates a reasonable probability of serious harm or death.

The affected product is Lot 504950, identified by National Drug Code 69680-166-00. The bottles carry an expiration date of September 30, 2026, according to the FDA notice.

FDA records show that 3,655 units from the affected lot were released, while 1,955 units were sold. The medication was distributed nationwide through Vitruvias’ direct accounts.

The distribution period ran from January 31 through September 30, 2025. Vitruvias said it notified wholesalers to stop distributing the recalled product and was arranging destruction of remaining inventory.

Why the Medication Was Recalled

The central concern is potency. Testing found the tablets could be stronger than intended, potentially exposing patients to more thyroid hormone than prescribed and increasing the risk of hyperthyroidism.

Thyroid Tablets, USP is a natural thyroid preparation derived from porcine thyroid glands. It contains levothyroxine and liothyronine, hormones used to treat people with an underactive thyroid.

When thyroid hormone levels become excessive, patients can develop hyperthyroidism. Possible symptoms include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, and rapid heartbeat.

The FDA also warns that excessive thyroid hormone can cause heart rhythm disturbances. These risks may become more significant when exposure continues for an extended period.

Who Could Face Greater Risk?

Certain patients face greater potential risks from excessive thyroid hormone exposure, including older adults, pregnant women, and infants, according to the FDA’s safety information.

For older adults, excess thyroid hormone has been associated with adverse cardiac outcomes. During pregnancy, overtreatment may increase maternal and fetal complications, including premature delivery and low birth weight.

In infants, excessive thyroid hormone exposure may negatively affect growth and development. The FDA therefore highlights infants among the groups requiring particular attention when medication potency is excessive.

Vitruvias said it had not received reports of adverse events known to be related to the recalled product when the original recall announcement was issued.

What Should Patients Do?

Patients taking the affected lot should not independently stop treatment. The company and FDA advise contacting a healthcare provider for guidance and, if appropriate, a replacement prescription.

Consumers can check their medication packaging for the product name, 30 mg strength, NDC 69680-166-00, and Lot 504950. The expiration date is another identifying detail.

People who believe they experienced a problem related to the medication should contact a healthcare professional. Suspected adverse reactions can also be reported through the FDA’s MedWatch program.

What the Class I Label Means

The recall applies specifically to one lot of Vitruvias Thyroid Tablets, USP 30 mg. It does not mean that all thyroid medications or all Vitruvias products have been recalled.

The Class I designation reflects the potential severity of the product risk, not evidence that every patient who received the recalled tablets has been harmed.

The case highlights why patients should verify recall information carefully, avoid making abrupt medication changes, and discuss affected prescriptions with qualified healthcare professionals before changing treatment.

Key takeaway: The FDA’s Class I designation concerns one specific lot — 504950 — of Vitruvias Thyroid Tablets, USP 30 mg. Patients should check their packaging and consult their healthcare provider if their medication matches the recalled lot.