Karmactive Staff
If you take prescription thyroid hormone replacement medication, one specific lot has been reclassified by the FDA as a Class I recall — the agency’s most serious category, used when a product may cause serious health consequences or death. The product is Vitruvias Thyroid Tablets USP 30 mg. The affected lot number is 504950. If that code appears on your prescription bottle, contact your healthcare provider or pharmacist before making any changes to your medication.
What the recall covers
The FDA first announced a recall of this product in August 2026. On September 22, it upgraded the classification to Class I. The affected product is Vitruvias Thyroid Tablets USP 30 mg, lot 504950, NDC 69680-166-00, with an expiration date of September 30, 2026. It was distributed nationwide in the U.S. through Vitruvias Therapeutics’ direct accounts.
The reason for the recall is potential superpotency — meaning the tablets may contain more active thyroid hormone than the label states. For a drug taken daily to regulate metabolism, heart rate, and body temperature, excess thyroid hormone can cause hyperthyroidism and related cardiovascular and other health effects.
Why this matters if you take thyroid medication
If the tablets contain more thyroid hormone than labeled, continuing to take them can trigger thyrotoxicosis — a state of excess thyroid hormone that can cause rapid and irregular heartbeat, severe anxiety, high blood pressure, and heat intolerance. The FDA’s risk statement specifically names cardiac arrhythmias as a possible outcome. The FDA identifies elderly patients, pregnant women, and infants as groups at greater risk from superpotent thyroid tablets.
The danger cuts in both directions, though. The FDA advises patients not to stop taking their medication without first contacting their healthcare provider, as abrupt changes to thyroid hormone therapy require medical guidance. That means the correct response is not to simply stop taking the medication. Check your bottle’s lot number, call your pharmacy, and ask about obtaining a replacement from an unaffected lot. Do not stop or adjust your medication without speaking to your prescribing doctor or pharmacist first.
Pharmacies can verify the lot number against the FDA recall database and coordinate a replacement. If you are unsure how to read the lot number on your label, your pharmacist can help you identify it over the phone.
The expiration date on lot 504950 is September 30, 2026. Anyone currently taking this product should check their bottle today. Related Karmactive coverage includes the earlier Vitruvias lot 504950 update and a separate levothyroxine recall involving thyroid-tablet potency concerns.
FAQ
Which thyroid tablets are part of this recall?
The recalled product is Vitruvias Thyroid Tablets USP 30 mg, lot number 504950, NDC 69680-166-00, expiration September 30, 2026. It was distributed nationwide in the U.S. Check your prescription bottle for the lot number printed on the label or packaging.
Should I stop taking my thyroid medication if it matches the recall?
No. The FDA advises patients not to discontinue thyroid hormone replacement without first speaking to their healthcare provider. Contact your pharmacy to ask about a replacement from an unaffected lot. Do not make any changes to your dosing before speaking with your prescriber or pharmacist.
What does a Class I FDA recall mean?
A Class I recall is the FDA’s highest-risk category. It means there is a reasonable probability that using the product will cause serious health consequences or death. Class II covers products that may cause temporary health problems; Class III covers products unlikely to cause harm but still violating FDA rules.
If the FDA expands this recall to additional lots or products, this article will be updated.
