Full Breakdown
FDA Issues Class I Recall for Vitruvias Thyroid Tablets
By Drooid · · How we work
Core Event: Nationwide Recall of 30 mg Thyroid Tablets
Vitruvias Therapeutics Inc. has withdrawn one lot of its 30 mg “Thyroid Tablets, USP” after the U.S. Food and Drug Administration (FDA) classified the recall as a Class I event, the agency’s highest risk category. The recall applies to tablets that may be super-potent—stronger than intended—and were distributed across the United States during a nine-month period earlier this year.
Background & Context: Recall Process and Risk Category
A Class I recall indicates that use of the product is likely to cause serious health effects or death. The FDA’s classification, announced last month, follows a notice issued in August that described the potency issue and the potential for over-active thyroid symptoms such as rapid weight loss, heat intolerance, fatigue, and hypertension.
Data & Statistics: Scope of the Affected Lot
- National Drug Code: 69680-166-00; Lot number: 504950.
- Approximately 3,600 tablets were produced; about 1,900 units were sold before the recall.
- Distribution occurred nationwide from late January through late September of the previous year.
- All tablets bear an expiration date later this year.
Official Statements & Responses: FDA and Vitruvias Position
The FDA’s notice states that the tablets’ excess potency poses a serious health risk, prompting the Class I designation. Vitruvias Therapeutics reported that, as of the August notice, it had received no adverse-event reports linked to the affected lot. The company’s communication advises patients not to discontinue use without consulting a health-care provider and offers a dedicated safety email and phone line for inquiries.
Consumer Guidance: Steps for Patients
Patients who may have the recalled tablets should verify the NDC and lot number on their packaging. If the product matches the recalled identifiers, they should contact their prescriber before stopping the medication. For additional information or to return the tablets, consumers can reach Vitruvias at the provided email address or telephone number.
