The FDA raised the recall of Vitruvias Therapeutics’ thyroid tablets, lot 504950, to Class I, its most serious category for situations with a reasonable probability of serious harm or death. The tablets may be superpotent.
The lot was distributed nationwide to Vitruvias Therapeutics’ direct accounts from Jan. 31 to Sept. 30, 2025; nearly 2,000 bottles were issued. The FDA said elderly patients and pregnant women face greater risk of adverse effects. The tablets expire Sept. 30, 2026.
Vitruvias had notified wholesalers to stop distributing the recalled tablets and arrange their destruction. The company said online that it had ceased operations and that all its products are now owned and/or distributed by H2-Pharma LLC.
