The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of one lot of Thyroid Tablets, USP 30 mg distributed by Vitruvias Therapeutics, Inc. The recall was issued after testing found that the tablets may be superpotent, meaning they could contain more thyroid hormone than intended.
For people who rely on thyroid medication every day, this recall is important because taking too much thyroid hormone can cause symptoms of hyperthyroidism, or an overactive thyroid. While no illnesses related to this recall have been reported so far, patients with the affected medication should know what to look for and what steps to take.
What Medication Is Being Recalled?
The recall affects one lot only of Thyroid Tablets, USP 30 mg.
The recalled product can be identified by:
- Lot Number: 504950
- NDC: 69680-166-00
- Expiration Date: September 30, 2026
The medication was distributed nationwide between January 31, 2025, and September 30, 2025.
The tablets are used to treat hypothyroidism, also known as an underactive thyroid. They contain natural thyroid hormones that help replace hormones the body is not making on its own.
Why Was It Recalled?
Testing found that the tablets may be more potent than labeled. This means patients could receive a higher dose of thyroid hormone than intended.
Too much thyroid hormone can cause hyperthyroidism, which speeds up many of the body’s normal processes. The severity of symptoms depends on how much extra hormone is taken and how long it is taken.
What Symptoms Should You Watch For?
If you have the recalled medication, watch for signs of excess thyroid hormone, including:
- Rapid or pounding heartbeat
- Irregular heart rhythm
- Chest pain
- Feeling unusually hot or sweating more than normal
- Unexplained weight loss
- Nervousness or anxiety
- Shaking or tremors
- Muscle weakness
- Fatigue despite feeling restless
More severe cases can lead to dangerous heart rhythm problems, especially in people who already have heart disease.
Who Is at the Highest Risk?
Anyone taking the affected medication could develop symptoms, but some groups are at greater risk of serious complications.
These include:
- Older adults
- People with heart disease
- Pregnant women
- Infants and young children
Too much thyroid hormone in older adults can increase the risk of heart-related complications. During pregnancy, excessive thyroid hormone replacement has been associated with complications such as premature delivery and low birth weight. In infants, prolonged overtreatment may affect normal growth and development.
What Should You Do If You Have the Recalled Medication?
If your prescription matches the recalled lot, do not stop taking it on your own.
Instead:
- Check your bottle to see if it matches the recalled lot number.
- Contact your pharmacist or healthcare provider as soon as possible.
- Ask about obtaining a replacement prescription.
- Seek medical attention right away if you develop symptoms such as chest pain, a racing heartbeat, or severe nervousness.
Because thyroid hormone replacement is essential for many people, suddenly stopping treatment without medical guidance can also cause health problems. Your healthcare provider can help you safely transition to a replacement medication if needed.
What This Means for You
This recall affects only one specific lot of Thyroid Tablets, USP 30 mg, not all thyroid medications. If you take thyroid medicine, there is no need to panic, but it is important to check your prescription bottle.
If your medication matches the recalled lot, contact your healthcare provider or pharmacist promptly. Recognizing the symptoms of excess thyroid hormone and getting medical advice early can help prevent more serious complications.
Source
- U.S. Food and Drug Administration. Vitruvias Therapeutics, Inc Issues Nationwide Recall of One Lot of Thyroid Tablets, USP 30 mg Due to Potential Super Potency. Available from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vitruvias-therapeutics-inc-issues-nationwide-recall-one-lot-thyroid-tablets-usp-30-mg-due-potential. Accessed August 26, 2026.
- Ross DS. Hyperthyroidism and Other Causes of Thyrotoxicosis. In: Feingold KR, Anawalt B, Blackman MR, et al., editors. Endotext. South Dartmouth (MA): MDText.com, Inc.; Available from: https://www.ncbi.nlm.nih.gov/books/NBK279036/. Accessed August 26, 2026.
