As of September 24, 2026, the FDA has placed one lot of Vitruvias Therapeutics Thyroid Tablets, USP 30 mg, in Class I, the agency’s highest recall category. The recall started in August after testing found that the tablets could be superpotent, meaning they may contain more thyroid hormone activity than intended.
That raises a practical question for anyone with an older bottle at home: does your medicine match the recalled lot?
Which Vitruvias thyroid tablets are part of the recall?
The thyroid tablets recall covers one specific lot of Thyroid Tablets, USP 30 mg. The product is sold in 100-tablet bottles. DailyMed lists the 30 mg product under NDC 69680-166-00.
Check the label for these details:
- NDC: 69680-166-00
- Lot: 504950
- Expiration date: September 30, 2026
- Units released: 3,655
- Units sold: 1,955
- U.S. distribution: January 31, 2025 through September 30, 2025
The FDA says Lot 504950 was distributed nationwide through Vitruvias Therapeutics’ direct accounts during that period. The recall does not cover every Vitruvias thyroid product.
See Lot 504950 on your bottle? Keep it nearby and call your pharmacist or prescriber. A photo of the label can make the check easier.
The FDA describes this medicine as a natural thyroid preparation made from porcine, or pig, thyroid glands. It contains levothyroxine, known as T4, and liothyronine, known as T3.
What does “superpotent” mean?
It means the tablets may be stronger than the amount stated on the label.
Thyroid replacement medicines give the body the hormone that the thyroid may be unable to make in enough quantity. Too little hormone can leave hypothyroidism untreated. Too much can push the body into a state similar to an overactive thyroid.
That is the main safety issue in this thyroid medication recall.
Too much thyroid hormone may cause nervousness, sweating, heat intolerance, weakness, weight loss, high blood pressure, a fast heartbeat, chest pain, or an abnormal heart rhythm. The FDA says older adults, pregnant women, and infants face greater risk, especially with longer exposure.
Why did the FDA raise the recall to Class I?
Class I is the FDA’s highest recall category. The agency uses it when there is a reasonable probability that use of, or exposure to, a recalled product could cause serious health consequences or death.
That classification describes the risk linked to the recalled product. It does not mean every person who took Lot 504950 has been seriously harmed.
Vitruvias announced the voluntary recall on August 21, 2026. The FDA published the company announcement on August 24. The recall was later classified as Class I on September 22, according to current reporting based on the FDA enforcement record.
The company told wholesalers to stop distribution and said recalled stock would be destroyed. The original FDA notice stated that Vitruvias had received no reports of adverse events known to be linked to the recall at that time.
So the risk classification is serious, but it should not be read as proof that widespread injury has occurred.
What should you do if you have Lot 504950?
Do not change your thyroid treatment on your own.
The FDA says people taking Lot 504950 should contact their healthcare provider for advice and, when needed, a replacement prescription.
Call your pharmacist or prescriber with the following information in front of you:
- Product name
- 30 mg strength
- NDC 69680-166-00
- Lot 504950
- Expiration date
You can ask, “Is my Lot 504950 product part of the recall, and what should I take instead?”
Do not replace it with an older thyroid prescription sitting at home. Thyroid medicines can contain different hormone combinations and strengths, so the replacement should match your treatment needs.
Running low on tablets? Tell the pharmacist or prescriber during the call. That gives the healthcare team time to arrange another prescription before the supply ends.
What symptoms could mean you are getting too much thyroid hormone?
An excess amount may cause symptoms linked with an overactive thyroid.
You could feel nervous or restless. Sleep may become harder. You might sweat more, feel unusually warm, lose weight without trying, or develop muscle weakness.
Heart symptoms deserve quick medical attention. A fast or irregular heartbeat, strong pounding in the chest, chest discomfort, dizziness, or fainting can occur with excess thyroid hormone. MedlinePlus lists chest pain, rapid or irregular heartbeat, shaking, sweating, confusion, seizures, and loss of consciousness among serious symptoms linked with thyroid hormone overdose.
These symptoms do not prove that the recalled tablets caused the problem. Many conditions can produce similar symptoms. A new or worsening symptom still deserves medical advice.
Seek emergency medical care for chest pain, severe shortness of breath, fainting, seizure, severe confusion, or a very fast or irregular heartbeat.
Who may face greater risk?
The FDA names older adults, pregnant women, and infants as groups at greater risk from excess thyroid hormone.
For older adults, excess thyroid hormone can be especially concerning for the heart.
Pregnancy requires close medical follow-up since thyroid treatment affects both the pregnant patient and the developing baby. The FDA says overtreatment in pregnancy has been associated with maternal and fetal problems, including premature delivery and low birth weight.
Infants need careful dosing too. The FDA says excess treatment in infants may affect growth and development. Parents and caregivers should speak with the prescribing clinician or pharmacist before changing a baby’s medicine.
How would a doctor check for a possible problem?
The visit usually starts with a medication review and a check of symptoms.
Blood tests can help show whether thyroid hormone levels are too high. TSH is one of the main thyroid tests, and free T4 measures the amount of T4 circulating in the blood. The American Thyroid Association lists TSH and free T4 as the main blood tests used to assess thyroid function in hypothyroidism.
A doctor may order an ECG, which records the heart’s electrical activity, if you have palpitations, a fast pulse, chest symptoms, or concern about an abnormal rhythm. ECG testing is among the tests used in thyroid hormone overdose assessment.
The tests chosen depend on the person’s symptoms, age, pregnancy status, medical history, dose, and length of use.
A blood test cannot show that a particular tablet was superpotent. It can show whether hormone levels are too high and help the clinician decide what should happen next.
Should you stop the recalled tablets right away?
This is where many patients may hesitate.
The FDA says people taking Lot 504950 should not stop the medicine without contacting their healthcare provider for advice or a replacement prescription.
There are two issues here. The recalled tablets may provide more thyroid hormone than intended. Stopping thyroid replacement without another treatment in place can leave hypothyroidism untreated.
The American Thyroid Association advises patients to take thyroid hormone as prescribed and discuss treatment changes with their doctor.
So, if your bottle matches the recalled lot, contact the pharmacist or prescriber before making a change.
What if you already took some of the recalled tablets?
Taking a recalled tablet does not mean you were harmed.
Tell your pharmacist or prescriber how much you were taking, how many tablets you used, and how long you had that lot. Depending on your situation, they may suggest blood tests, symptom checks, heart monitoring, or a replacement medicine.
Report new or worsening symptoms such as a racing or irregular heartbeat, sweating, shaking, sleep problems, heat intolerance, weight loss, weakness, chest pain, or breathing trouble.
Keep the bottle until you receive instructions about disposal.
For recall questions, the FDA notice lists Vitruvias Therapeutics at safety@vitruvias.com and 256-239-9373, Monday through Friday from 9 a.m. to 5 p.m. Central Time. Suspected reactions or product quality problems can be reported through FDA MedWatch.
Does this recall affect all thyroid medicines?
No.
The thyroid medication recall involves one lot of one product: Thyroid Tablets, USP 30 mg, Lot 504950. It does not mean every levothyroxine prescription, every liothyronine prescription, or every desiccated thyroid product is part of this recall.
The recalled medicine is made from porcine thyroid tissue and contains T4 and T3. The American Thyroid Association identifies synthetic levothyroxine as the standard treatment for hypothyroidism. Desiccated thyroid extract contains both T4 and T3 and is used by some patients, though the ATA does not recommend it as first-line treatment.
A replacement should be selected based on the person’s diagnosis, previous treatment, blood tests, symptoms, pregnancy status, age, and other medical needs.
What should you ask your pharmacist or doctor?
Ask whether Lot 504950 is affected, whether you need a replacement, what product and dose you should use, whether thyroid blood tests are needed, and whether your symptoms call for an ECG or urgent care.
Have the bottle and your current medicine list beside you during the call. That can help prevent mix-ups.
What if you live outside the United States?
The FDA notice concerns U.S. distribution. If you obtained the medicine through an international seller, keep the packaging and ask the seller, pharmacist, or local healthcare provider to confirm the product and lot number.
FAQs
Is Lot 504950 the only lot named in this recall?
Yes. The FDA recall notice identifies Lot 504950 for Thyroid Tablets, USP 30 mg. The thyroid tablets recall does not cover every lot or every strength sold by Vitruvias.
How can I check whether my bottle is affected?
Look at the label for the NDC, strength, lot number, and expiration date. The matching details are NDC 69680-166-00, Lot 504950, 30 mg, and an expiration date of September 30, 2026.
What is the safest response to the Vitruvias thyroid recall?
Contact your prescribing clinician or pharmacist before stopping the medicine or choosing a replacement. The FDA says current users of Lot 504950 should seek medical guidance and, when needed, a replacement prescription.
Can a superpotent thyroid tablet cause hyperthyroidism?
Yes. Too much thyroid hormone can cause symptoms such as weight loss, heat intolerance, nervousness, sweating, weakness, high blood pressure, a fast heartbeat, and abnormal heart rhythms.
What if I have chest pain after taking the recalled medicine?
Seek emergency medical care. Chest pain can have many causes, so do not assume it is from the medicine. Severe shortness of breath, fainting, seizure, severe confusion, or a very fast or irregular heartbeat need urgent assessment.
Is the current thyroid medication recall a warning about all thyroid treatment?
No. It concerns one recalled lot of one Vitruvias product. Patients should not stop another thyroid medicine just because this recall was announced. Any change should be made with the clinician managing the treatment.
The lot number is the key detail
Have Thyroid Tablets, USP 30 mg from Vitruvias Therapeutics at home? Check the bottle.
The recalled lot is 504950. The NDC is 69680-166-00. The expiration date is September 30, 2026.
The FDA’s Class I classification means the agency considers the recalled product to present a reasonable probability of serious health consequences or death if people are exposed to it. It does not mean every patient who used the product has been harmed.
The practical step is clear: check the bottle, contact your pharmacist or prescriber, and do not make an unplanned change to thyroid treatment. Severe symptoms such as chest pain, fainting, seizures, severe breathing trouble, or a very fast or irregular heartbeat need emergency medical care.
