The U.S. Food and Drug Administration announced today that it has elevated the recall of a lot of thyroid medication produced by Vitruvias Therapeutics Inc. to the agency’s highest danger classification, Class I. A Class I recall signals that exposure to the product poses a reasonable probability of serious health consequences or death.
Why the recall was upgraded
Vitruvias Therapeutics voluntarily recalled the 30 mg thyroid tablets under lot number 504950 on Aug. 24 after discovering that the tablets could be super‑potent. Over‑potent thyroid medication can trigger hyperthyroidism, leading to rapid weight loss, heat intolerance, extreme fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate, and irregular heart rhythms.
Scope of the affected product
The FDA says roughly 1,955 bottles of the affected lot were distributed nationwide to direct accounts between Jan. 31 and Sept. 30. The agency notes that elderly individuals, pregnant women and infants are at the greatest risk of severe complications, particularly if they take the medication over an extended period.
Company response and next steps
Vitruvias Therapeutics reported that, at the time of the initial August announcement, it had received no adverse‑reaction reports linked to the recalled lot. The company has begun contacting wholesalers by telephone and email to halt distribution and to coordinate the destruction of any remaining inventory.
Medical officials advise patients who may have received the recalled tablets not to stop taking their medication without first consulting their prescribing physician. Consumers with questions can reach Vitruvias Therapeutics by email at [email protected] or by phone at (256) 239‑9373, Monday through Friday, 9 a.m. to 5 p.m. Central time.
About the medication
The recalled tablets are natural porcine‑derived preparations containing levothyroxine and liothyronine, commonly prescribed to treat hypothyroidism. Patients who rely on these hormones to regulate their metabolism should verify with their healthcare provider whether they have been prescribed the affected lot.
What patients should do
If you have been prescribed Vitruvias 30 mg thyroid tablets, check the lot number on your prescription bottle. The lot number for the recalled product is 504950. If your medication matches this number, contact your pharmacy or doctor immediately to arrange a safe replacement. Do not discard the medication on your own; follow the company’s instructions for proper disposal.
The FDA will continue to monitor the situation and work with Vitruvias Therapeutics to ensure that any remaining products are removed from the market. This action underscores the agency’s commitment to protecting public health by swiftly addressing potential drug safety issues.
Original reporting: KTBS 3 (Shreveport) — read the source article.
