Vitruvias Therapeutics Thyroid Tablet Recall: Lot 504950 Recalled Over Potential Super Potency

Vitruvias Therapeutics thyroid tablet recall involves one nationwide lot of Thyroid Tablets, USP 30 mg after testing confirmed the potential for the product to be superpotent. The voluntary consumer-level recall was announced by Vitruvias Therapeutics on August 21, 2026, and the U.S. Food and Drug Administration published the safety notice on August 24. The affected product is Lot 504950, with an expiration date of September 30, 2026.

The recall does not cover every Vitruvias thyroid tablet. It specifically applies to the 30 mg product identified by National Drug Code 69680-166-00 and Lot 504950. The company distributed the affected lot nationwide through its direct accounts between January 31, 2025, and September 30, 2025.

The recall is important because thyroid medication containing excessive hormone levels can potentially cause hyperthyroidism. Symptoms may include rapid heart rate, nervousness, muscle weakness, heat intolerance, weight loss, high blood pressure, chest pain and heart rhythm disturbances.

Vitruvias Therapeutics said it has not received reports of adverse events known to be related to this recall as of the latest announcement.

What Is the Vitruvias Therapeutics Thyroid Tablet Recall?

Vitruvias Therapeutics voluntarily recalled one lot of Thyroid Tablets, USP 30 mg after testing confirmed that the product could be superpotent.

In practical terms, superpotency means the medication may contain more active thyroid hormone than intended. Thyroid Tablets, USP contain both levothyroxine, also known as T4, and liothyronine, also known as T3.

The affected medication is a prescription thyroid product used in the treatment of hypothyroidism, a condition in which the body does not produce enough thyroid hormone.

The recall is limited to one lot. Patients should therefore identify the product by checking the medication bottle, prescription packaging and lot information rather than assuming that every Vitruvias thyroid tablet has been recalled.

The key identifying information is:

The FDA’s current recall listing identifies the recall as a drug safety action involving potential super potency.

Why Was the 30 mg Thyroid Tablet Recalled?

The central issue is the potential for the recalled lot to be stronger than intended.

Thyroid Tablets, USP are natural thyroid hormone preparations derived from porcine thyroid glands. The 30 mg strength contains levothyroxine and liothyronine as active thyroid hormones.

The product labeling identifies 30 mg, or one-half grain, as containing 19 micrograms of levothyroxine and 4.5 micrograms of liothyronine per tablet.

If thyroid hormone exposure becomes excessive, the body can develop signs associated with hyperthyroidism. That is the primary safety concern behind the recall.

The company specifically cited testing that confirmed the potential for super potency. The recall announcement did not identify a broader defect involving every strength or every lot of the product.

That distinction matters for patients who use thyroid medication. The current recall concerns Lot 504950 of the 30 mg tablets, rather than automatically applying to all Vitruvias thyroid products.

Which Vitruvias Thyroid Tablets Are Affected?

Patients can determine whether they have the recalled product by checking three important pieces of information on their medication packaging: the product strength, NDC number and lot number.

The affected product is:

Thyroid Tablets, USP 30 mg — NDC 69680-166-00 — Lot 504950 — expiration date September 30, 2026.

The 30 mg tablets are labeled as one-half grain. Product information identifies the tablets as prescription medication distributed by Vitruvias Therapeutics.

Other strengths listed in product information include 15 mg, 60 mg, 90 mg and 120 mg. The current recall announcement does not identify those strengths as part of Lot 504950.

Patients should not rely only on the appearance of a tablet to determine whether it is recalled. The lot number on the container provides a much more reliable way to identify the affected medication.

If the original bottle is unavailable, a pharmacist can help determine whether the medication came from the recalled lot.

How Many Tablets Were Distributed?

The recall involves a relatively specific quantity of product.

Vitruvias Therapeutics reported that 3,655 units of the affected lot were released. Of those, 1,955 units were sold.

The company distributed Lot 504950 nationwide to its direct accounts. Distribution began January 31, 2025, and continued through September 30, 2025.

Because the affected lot reached direct accounts across the United States, patients in multiple states could potentially have received the recalled medication.

The nationwide distribution does not mean every patient taking Vitruvias Thyroid Tablets has an affected bottle. The recall remains tied to the specific lot number.

What Health Problems Can Superpotent Thyroid Tablets Cause?

Excess thyroid hormone can push the body toward a state of hyperthyroidism.

The recall warning identifies several possible symptoms and complications. These include:

• Weight loss
• Heat intolerance
• Fatigue
• Nervousness
• Muscle weakness
• High blood pressure
• Chest pain
• Rapid heart rate
• Heart rhythm disturbances

The potential effects can vary between individuals. The risk also depends on factors such as the amount of excess hormone exposure and the duration of exposure.

The recall notice highlights elderly patients, pregnant women and infants as groups that can face greater risks from excessive thyroid hormone exposure.

For older adults, excessive thyroid hormone levels can create particular concerns involving the cardiovascular system.

During pregnancy, overtreatment of hypothyroidism has been associated with increased maternal and fetal complications, including premature delivery and low birth weight.

In infants, excessive thyroid hormone exposure can negatively affect growth and development.

These concerns make it especially important for patients and caregivers to identify whether their medication belongs to the recalled lot.

Should Patients Stop Taking the Recalled Thyroid Tablets?

The recall notice gives an important instruction for patients who are currently taking the affected medication.

Patients taking Thyroid Tablets, USP from Lot 504950 should not discontinue the medication without first contacting their healthcare provider for guidance and, when appropriate, a replacement prescription.

That instruction is significant because suddenly changing thyroid hormone treatment without medical guidance can also create health concerns.

Patients who discover that they have Lot 504950 should contact their prescribing healthcare professional or pharmacist and tell them that the medication is part of the Vitruvias Therapeutics recall.

A healthcare professional can determine the appropriate next step and whether a replacement prescription is needed.

Patients should not independently change the dose or substitute another thyroid medication without professional guidance.

What Should Patients Do If They Have Lot 504950?

Patients who identify the recalled lot should take several practical steps.

First, check the bottle carefully and confirm that the product is Thyroid Tablets, USP 30 mg and that the lot number is 504950.

Second, contact the prescribing healthcare professional or pharmacist. Explain that the medication has been identified in the current Vitruvias Therapeutics recall.

Third, follow the healthcare professional’s instructions regarding continued treatment and replacement medication.

Fourth, do not assume that every thyroid tablet made by Vitruvias Therapeutics is affected. The current recall is specific to Lot 504950.

Patients who have experienced a health problem that they believe may be connected to the recalled medication should also discuss the issue with their healthcare provider.

The company has provided a consumer contact number, (256) 239-9373, available Monday through Friday from 9 a.m. to 5 p.m. Central Time. Consumers can also contact Vitruvias Therapeutics at safety@vitruvias.com about the recall.

What Is the Expiration Date of the Recalled Lot?

The affected Lot 504950 carries an expiration date of September 30, 2026.

That date is another identifying detail for patients checking their medication.

However, patients should not rely on the expiration date alone. A product can share the same strength and expiration date while having a different lot number.

The combination of the product, NDC and lot number provides the clearest identification.

For the current recall, the critical combination is:

Thyroid Tablets, USP 30 mg + NDC 69680-166-00 + Lot 504950.

Is the Recall Still Active?

The FDA’s current recall database lists the Vitruvias Therapeutics thyroid tablet recall dated August 24, 2026. The listing does not show the recall as terminated.

That means the recall remains an active safety matter as of August 25, 2026.

Vitruvias Therapeutics said it was notifying wholesalers by email and telephone and arranging for destruction of recalled product.

The company is taking steps to stop further distribution of the affected lot.

Patients should therefore treat Lot 504950 as recalled and contact their healthcare professional for instructions if they have the affected medication.

Has Vitruvias Reported Any Adverse Events?

The latest recall announcement states that Vitruvias Therapeutics has not received reports of adverse events known to be related to this recall.

That information does not eliminate the potential safety concern identified by testing. The recall was initiated because the product was found to have the potential to be superpotent.

Patients who experience symptoms they believe could be associated with the medication should contact a healthcare professional.

The FDA also encourages reporting adverse events or product quality problems through its MedWatch safety reporting program.

What Ingredients Are in Vitruvias Thyroid Tablets?

The affected medication belongs to a class of natural thyroid preparations containing two thyroid hormones.

The 30 mg, or one-half-grain, product contains:

• Levothyroxine (T4): 19 mcg
• Liothyronine (T3): 4.5 mcg

The product is derived from porcine thyroid glands.

The medication’s labeling also identifies inactive ingredients including microcrystalline cellulose, lactose, silicon dioxide and magnesium stearate.

The presence of both T4 and T3 is relevant to the recall because excessive thyroid hormone exposure can produce symptoms associated with an overactive thyroid.

Why Checking the Lot Number Matters

Medication recalls can sometimes create confusion because a product name may remain the same across multiple manufacturing lots.

In this case, the recall does not identify every Vitruvias Thyroid Tablet as affected. It identifies a specific lot of the 30 mg product.

That makes the lot number particularly important.

Patients should look for 504950 on the packaging. They should also verify that the medication is the 30 mg product with NDC 69680-166-00.

If the information on the bottle is difficult to read, a pharmacist can assist with identification.

Patients should avoid discarding medication before receiving appropriate guidance if doing so could interrupt their prescribed thyroid treatment.

What the Latest Recall Update Means for U.S. Patients

As of August 25, 2026, the key facts remain straightforward.

Vitruvias Therapeutics has voluntarily recalled one lot of Thyroid Tablets, USP 30 mg because testing confirmed the potential for super potency.

The affected lot is 504950.

The NDC is 69680-166-00.

The expiration date is September 30, 2026.

The affected lot was distributed nationwide between January 31, 2025, and September 30, 2025.

The company reported that 3,655 units were released and 1,955 were sold.

Vitruvias Therapeutics has not reported adverse events known to be connected to the recall as of its latest announcement.

The FDA’s recall listing remains active and does not identify the recall as terminated.

Patients currently using the affected lot should contact their healthcare provider before making changes to their thyroid medication regimen.

Bottom Line on the Vitruvias Therapeutics Thyroid Tablet Recall

The current safety action centers on one specific product and lot rather than all thyroid medication made or distributed by Vitruvias Therapeutics. The recalled product is Thyroid Tablets, USP 30 mg, NDC 69680-166-00, Lot 504950, with an expiration date of September 30, 2026.

The reason for the recall is the potential for super potency confirmed through testing. Excess thyroid hormone exposure can lead to hyperthyroidism and potentially serious symptoms, including rapid heart rate and heart rhythm disturbances.

Patients should check their medication packaging carefully. Anyone who finds Lot 504950 should contact a healthcare professional for guidance and a potential replacement prescription rather than independently stopping treatment.

The latest confirmed information does not indicate reported adverse events linked to the recall, but the company and FDA are treating the potential super potency as a product safety concern.

Check your medication lot carefully, follow your healthcare provider’s guidance, and stay alert for further confirmed updates on this recall.