The US Food and Drug Administration (FDA) has upgraded a recall of thyroid medication to its most serious classification after the manufacturer halted operations.
Initially, Vitruvias Therapeutics announced a voluntary recall of one lot of its thyroid tablets over concerns that the drug could be “superpotent,” suggesting the thyroid medication may entail more active ingredient than intended.
The vulnerable group include elderly individuals and pregnant women, who are at a significantly increased risk of adverse effects.
The affected lot, identified by number 504950, was distributed all across the nation to Vitruvias Therapeutics’ direct accounts between January 31 and September 30, 2025. The tablets had an expiration date of September 30, 2026.
This week, the FDA reclassified the recall as Class I. As per the agency, this is said to be the most serious recall category and applies when there is a reasonable probability that using or being exposed to a recalled product could cause serious health consequences or death.
Previously, Vitruvias Therapeutics instructed wholesalers to stop distributing the affected drug and arrange for the recalled drugs to be destroyed.
Nearly 2,000 bottles have been distributed. The recall follows Vitruvias Therapeutics announcing online that it had “ceased operations.” The company stated its items are now owned or distributed by H2-Pharma LLC.
Patients who may have received the recalled drug are required to check the product and lot number with their pharmacist or healthcare provider and follow official FDA guidance rather than stopping a prescribed thyroid medicine without medical advice.
