The U.S. FDA classifies the recall of one lot of Vitruvias Therapeutics 30 mg thyroid tablets as Class I, its highest-risk category. In the FDA’s Sept. 22 action, the agency says the recalled tablets may pose a serious risk to health.

According to reports, the concern is that the tablets could be more potent than intended (“superpotent”), which could trigger significant health effects, including possible heart-related problems. Mint reports the affected lot contains about 3,655 units. Quartz likewise notes that the FDA upgraded the recall to Class I, indicating the agency views the potential harm as the most serious among its recall classifications.

Both outlets describe the same FDA classification and the same recalled product lot, but they emphasize different aspects: Quartz focuses on the escalation to the highest recall category, while Mint highlights the potential medical consequences and the approximate quantity involved.