The FDA raised Vitruvias Therapeutics’ recall of one lot of 30 mg thyroid tablets to Class I, its highest warning level. The company said the tablets were stronger than intended; patients should consult a provider before stopping or switching.
Vitruvias said the tablets were “superpotent” and could cause hyperthyroidism. Possible effects include weight loss, heat intolerance, fatigue, nervousness, muscle weakness and heart rhythm disturbances. Older adults, pregnant people and infants may be more vulnerable, especially with extended use. In August, the company said it had received no reports of adverse events known to be related to the recall.
The affected lot is 504950, labeled “Thyroid Tablets, USP.” About 1,900 units were sold from a batch of about 3,600, according to Vitruvias. The tablets were distributed from Jan. 31 to Sept. 30, 2025, and expire Sept. 30, 2026.
