FDA Issues Class I Recall for Vitruvias Thyroid Tablets Over ‘Superpotent’ Risk—Check Your Medicine Now

U.S. patients taking desiccated Thyroid Tablets USP 30 mg should immediately check their prescription bottles: Vitruvias Therapeutics Inc. has expanded its nationwide recall after the Food and Drug Administration (FDA) escalated the action to a Class I–its most urgent level–because the pills may be “superpotent,” delivering higher-than-labeled doses of thyroid hormone that can trigger life-threatening hyperthyroidism symptoms such as rapid heartbeat, chest pain, and severe weight loss. Key recall details • Affected product: Thyroid Tablets USP 30 mg, NDC 69680-166-05, lot 005049, expiration 09/30/2026. • Distribution: 3,655 bottles released, 1,955 sold between Jan 31 and Sep 30 2025 through wholesalers and retail pharmacies nationwide. • Reason: Post-market testing found the tablets exceed potency specifications, raising the risk of overdose, especially in older adults, pregnant patients, and infants. • FDA classification: Upgraded to Class I on Sept. 23 2026, indicating a reasonable probability of serious adverse health consequences or death. What patients should do 1. Locate the lot number on the prescription label; if it matches 005049, stop using the medication only after consulting your prescriber for a replacement or alternative therapy. 2. Contact your pharmacy for return instructions and reimbursement. 3. Report any side effects—heat intolerance, muscle weakness, palpitations, anxiety—to your healthcare provider and to FDA’s MedWatch program. Contact information Vitruvias Therapeutics safety line: 256-239-9373 (Mon–Fri, 9 a.m.–5 p.m. CT) or email safety@vitruvias.com. Why this matters Desiccated thyroid preparations contain both T3 and T4 hormones; even slight increases in potency can rapidly push blood levels into a dangerous range. Early intervention prevents complications such as arrhythmia, heart failure, or fetal harm in pregnancy. By acting now, consumers can avoid emergency room visits and ensure continuous, correctly dosed thyroid management. Search interest around “Vitruvias thyroid recall” is spiking, so share this alert with anyone who takes natural thyroid medication. Staying informed protects your health and helps the FDA trace any remaining bottles in circulation.