A nationwide recall affects one lot of Vitruvias Thyroid Tablets, USP 30 mg, after testing raised concerns about potentially excessive hormone levels.
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of one lot of Vitruvias Therapeutics’ Thyroid Tablets, USP 30 mg, after testing confirmed the possibility that the tablets may be superpotent. (1✔ ✔Trusted Source
Vitruvias Therapeutics, Inc Issues Nationwide Recall of One Lot of Thyroid Tablets, USP 30 mg Due to Potential Super Potency
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Taking thyroid medication with excessive hormone levels could trigger hyperthyroidism and may pose greater risks to older adults, pregnant women, and infants, particularly with prolonged exposure.
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Which Vitruvias Thyroid Tablets Are Being Recalled?
The recall involves Lot 504950 of Vitruvias Thyroid Tablets, USP 30 mg, with an expiration date of September 30, 2026. According to the FDA, the lot was distributed across the United States to Vitruvias Therapeutics’ direct accounts between January 31 and September 30, 2025.
The product details are:
- Product: Thyroid Tablets, USP 30 mg
- NDC: 69680-166-00
- Lot: 504950
- Expiration: September 30, 2026
- Units released: 3,655
- Units sold: 1,955
The FDA says the tablets are a natural preparation derived from porcine thyroid glands and contain levothyroxine and liothyronine, which are used to treat hypothyroidism.
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Why Can Superpotent Thyroid Tablets Be Dangerous?
The FDA says excessive thyroid hormone exposure can cause hyperthyroidism, with possible symptoms including:
- Weight loss
- Heat intolerance
- Fatigue
- Nervousness
- Muscle weakness
- High blood pressure
- Chest pain
- Rapid heartbeat
- Abnormal heart rhythms
Certain groups may face particular concerns. The FDA identifies older adults, pregnant women, and infants as being at greater risk, especially when excessive thyroid hormone exposure continues for an extended period.
In older adults, excess thyroid hormone can have adverse effects on the heart, while overtreatment during pregnancy has been associated with maternal and fetal complications. In infants, excessive treatment may negatively affect growth and development.
Vitruvias Therapeutics said it had not received reports of adverse events known to be associated with the recall at the time of the announcement.
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What Should Patients Taking This Thyroid Medicine Do?
Patients using Lot 504950 should not stop taking the medication on their own. The FDA says they should contact their healthcare provider for advice and, if appropriate, a replacement prescription.
Vitruvias is notifying wholesalers and asking them to stop distributing the recalled product while arranging for the recalled tablets to be destroyed.
Consumers who believe they have experienced a problem related to the medication should contact their healthcare provider and can also report adverse reactions or quality concerns through the FDA’s MedWatch program.
Reference:
- Vitruvias Therapeutics, Inc Issues Nationwide Recall of One Lot of Thyroid Tablets, USP 30 mg Due to Potential Super Potency – https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vitruvias-therapeutics-inc-issues-nationwide-recall-one-lot-thyroid-tablets-usp-30-mg-due-potential
Source-Medindia