Recall - Vitruvias Therapeutics (Thyroid Tablets, USP 30 mg) produced by Vitruvias Therapeutics, Inc - Potential for the Product to be Superpotent

Summary

Company Announcement

AUBURN, Ala. (August 21, 2026) - Vitruvias Therapeutics Inc. is voluntarily recalling one lot (Lot. No. 504950) of Thyroid Tablets, USP 30 mg to the consumer level. The product is being recalled because testing confirmed the potential for the product to be superpotent.

Risk Statement: Consumption of superpotent Thyroid tablets can cause hyperthyroidism (overactive thyroid) including, but not limited to, weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. The patient population at greater risk from superpotent thyroid are elderly, pregnant women, and infants, especially over extended periods of time. Excess levels of thyroid hormones in the elderly have been associated with adverse outcomes, particularly to cardiac health. Overtreatment of hypothyroidism in pregnancy is associated with a higher rate of maternal and fetal complications, including premature delivery and low birth weight. Overtreatment of hypothyroidism in infants may have negative effects on growth and development. To date, Vitruvias Therapeutics has not received any reports of adverse events known to be related to this recall.

Thyroid, USP is a natural preparation derived from porcine thyroid glands composed of levothyroxine and liothyronine and used to treat hypothyroidism (underactive thyroid).

To best identify the product, the NDC, Product Description, Lot Number, and Expiration Date are listed below.

Lot 504950 was distributed nationwide in the USA to Vitruvias Therapeutics' direct accounts from Jan. 31, 2025 to Sept. 30, 2025.

See product label for ease in identifying the product.

Vitruvias Therapeutics is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for destruction of all recalled product. Patients who are currently taking Thyroid, USP from Lot 504950, which is being recalled, should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can contact Vitruvias Therapeutics, Inc. by email at [email protected] or by phone at (256) 239-9373 Monday through Friday from 9 a.m. to 5 p.m. CT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.