Prescription pill bottle with white tablets spilled on a kitchen counter, representing a thyroid medication recall

Thyroid Medication Recall Just Got the FDA’s Highest Risk Rating — Here’s What to Check

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The FDA just classified a nationwide thyroid medication recall as Class I, its most serious risk category, reserved for situations where using the product could cause serious injury or death.

That’s the label now attached to one lot of Vitruvias Therapeutics Thyroid Tablets, USP, 30 mg.

Prescription pill bottle with white tablets spilled on a kitchen counter, representing a thyroid medication recall

A nationwide thyroid medication recall was just classified Class I by the FDA.

What Was Recalled

Vitruvias Therapeutics, based in Auburn, Alabama, is recalling one lot of its Thyroid Tablets, USP, 30 mg.

The affected lot number is 504950, with NDC 69680-166-00. The tablets were distributed nationwide.

Why It Was Recalled

Testing found the tablets may be superpotent, meaning they contain more active thyroid hormone than the label says.

Thyroid tablets are a hormone replacement medication. Taking more than your prescribed dose can push your body into a state similar to an overactive thyroid, called hyperthyroidism.

That can mean a racing heart, chest pain, irregular heart rhythms, tremors, and muscle weakness. The FDA says the risk is highest for elderly patients, pregnant women, and anyone with existing heart disease.

No illnesses have been reported so far tied to this specific lot.

Person checking the lot number on a prescription bottle label at home

Check your bottle for lot number 504950 before your next dose.

What to Do If You Have It

Check your prescription bottle for lot number 504950.

If it matches, do not stop taking the medication on your own. Suddenly stopping thyroid medication carries its own risks. Instead, call your doctor or pharmacist and ask about switching to a replacement lot.

You can also contact Vitruvias Therapeutics directly at (256) 239-9373 or safety@vitruvias.com, Monday through Friday, 9 a.m. to 5 p.m. Central time.

If you’ve noticed a racing heartbeat, chest pain, or other new symptoms since starting this medication, tell your doctor and consider reporting it to the FDA’s MedWatch program.

How to Verify This Recall

You can read the FDA’s full recall notice directly on FDA.gov.

For general background on how the FDA classifies recalls, see the agency’s recall classification guidance.

If you’re trying to stay on top of recalls that could affect your household, our recent coverage of the Wholesome Pantry apple sauce recall and the Bettergoods Alfredo Fettuccine Listeria recall walks through the same check-your-label steps.

FAQ

How do I know if my thyroid medication is affected?
Check the label on your prescription bottle for lot number 504950 and NDC 69680-166-00. Only this specific lot of Vitruvias Therapeutics Thyroid Tablets, USP, 30 mg is recalled.

Is it dangerous to keep taking it?
Possibly, if the tablets are superpotent. But do not stop taking thyroid medication on your own. Call your doctor first to arrange a safe replacement.

What symptoms should I watch for?
A racing or irregular heartbeat, chest pain, tremors, anxiety, excessive sweating, or muscle weakness. These can be signs of too much thyroid hormone.

Has anyone gotten sick from this?
No illnesses have been reported to date, according to the FDA notice.

What do I do with the recalled bottle?
Don’t discard it or stop taking it before talking to your doctor. They may want to see it, or you may need it to arrange a replacement prescription.

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