Thyroid Medication Recall Elevated to FDA's Highest Risk Level
The FDA said the tablets could be superpotent and may cause serious health effects, with about 1,900 units sold from the batch.
- On September 22, the FDA elevated the recall of Vitruvias Therapeutics thyroid tablets to a Class I designation, the agency's most serious classification, following the company's voluntary recall of lot 504950 initiated last month.
- Vitruvias Therapeutics initiated the recall after testing confirmed the medication could be 'superpotent,' or stronger than intended, potentially causing 'hyperthyroidism' and symptoms including weight loss, fatigue, and hypertension.
- The affected 'Thyroid Tablets, USP' were distributed nationwide between January 31 and September 30, 2025, with about 1,900 units sold from a batch of about 3,600, identifiable by National Drug Code 69680-166-00.
- Patients currently taking the medication should not stop without contacting a healthcare provider, the FDA advised, while Vitruvias Therapeutics stated it would notify retailers to discontinue distribution and arrange for 'destruction' of all recalled tablets.
- This recall follows separate actions taken over the summer regarding other thyroid medications, as Ohio-based Major Pharmaceuticals and North Carolina-based Accord Healthcare Inc. recalled different levothyroxine sodium products in July.
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FDA upgrades Vitruvias Therapeutics recall: Superpotent thyroid tablets could trigger heart problems; who is at risk?
The FDA has classified Vitruvias Therapeutics' recall of thyroid tablets as Class I due to potential superpotency, posing a risk of serious health issues. The affected lot includes approximately 3,655 units.
Thyroid Tablet Recall Upgraded to FDA’s Most Serious Risk Level—Drug May Be ‘Superpotent’
The FDA upgraded a recall of one lot of thyroid tablets to Class I after testing found the medication may be superpotent.Credit: WLADIMIR BULGAR/SCIENCE PHOTO LIBRARY / Getty ImagesWhat we’re talking about: One lot of Vitruvias thyroid tablets was upgraded to a Class I recall because it may be too strong.Why this matters: Superpotent thyroid medication can cause serious health problems, with pregnant women, infants, and older adults at greatest …
Thyroid medication recall elevated to highest risk level by FDA
نُشر هذا المقال أولاً عبر Cedarnews.net. لمتابعة المزيد من الأخبار والتقارير الحصرية، زورونا على موقعنا. Product Recall: The affected product carries NDC 69680-166-00, Lot No. 504950, with an expiration date of Sept. 30, 2026. Products affected and public. تم نشر هذا الخبر عبر موقع Cedarnews الإخباري. للاطلاع على مزيد من الأخبار العاجلة والتقارير الحصرية، زوروا موقعنا الرسمي.
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