Full Breakdown
Vitruvias Therapeutics Recalls One Lot of 30 mg Thyroid Tablets Over Potential Super-Potency
8/25/2026, 12:01:04 PM
Core Event: Voluntary Nationwide Recall Initiated
On August 21, 2026, Vitruvias Therapeutics Inc. announced a voluntary recall of lot 504950 of its Thyroid Tablets, USP 30 mg after testing indicated possible super-potency.
Background & Context: Product Description and Distribution History
Thyroid Tablets, USP are derived from porcine thyroid glands and contain levothyroxine (T4) and liothyronine (T3) for hypothyroidism therapy. The recalled lot (NDC 69680-166-00) was distributed nationwide from Jan 31 2025 to Sept 30 2025; 3,655 units were released, 1,955 sold. Expiration: Sept 30 2026.
Data & Statistics
| Item | Detail |
|---|---|
| Product | Thyroid Tablets, USP 30 mg |
| Lot number | 504950 |
| NDC | 69680-166-00 |
| Distribution period | Jan 31 2025 – Sept 30 2025 |
| Units released | 3,655 |
| Units sold | 1,955 |
| Expiration date | Sept 30 2026 |
Official Statements & Responses
Vitruvias said the recall is being conducted with FDA knowledge. Wholesalers are being notified by email and phone, and all recalled product will be destroyed. Patients are advised not to stop the medication without consulting a provider and to obtain a replacement if needed. Contact: 256-239-9373 or safety@vitruvias.com; adverse reactions should be reported to FDA MedWatch.
Risk Statement: Potential Health Effects
Inadvertent consumption of super-potent tablets can cause hyperthyroidism, with symptoms such as weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate, or arrhythmias. The company highlighted elderly patients, pregnant women, and infants as higher-risk groups.
Why It Matters: Clinical and Public-Health Implications
Excess thyroid hormone can trigger serious cardiovascular and metabolic complications, especially in vulnerable populations. The recall emphasizes the need for rigorous potency testing of compounded hormone products.
What’s Next: Ongoing Monitoring and Disposal
Vitruvias is working with wholesalers to stop distribution and destroy remaining inventory. The company will monitor for adverse events and update the FDA and public as needed. Patients should stay in contact with their healthcare providers and report any related symptoms.
