Class I — High Risk Severity Status: Ongoing Authority: FDA

THYROID

Recalling Firm / Manufacturer: VITRUVIAS THERAPEUTICS INC (Auburn, AL, United States)
FDA Recall Number: D-0866-2026
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
THYROID
Generic Name
THYROID
Active Substance(s)
Thyroid
Administration Route
Oral
National Drug Code (NDC)
69680-165
Total Quantity Recalled
1955 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

Superpotent Drug

Full Product Description
Packaging specifications and labeling details

Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 69680-166-00.

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
September 23, 2026
Firm Initiation Date
August 21, 2026
FDA Classification Date
Sep 22, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # 504950, Exp Date: 09/30/2026.
Distribution Information
Geographic scope of affected shipments

US Nationwide.

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
Related Questo Medical Knowledge
Clinical cases and condition overviews related to this medication

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0866-2026
Questo Retrieval Date: September 29, 2026 12:00 1790683214UTCC
View Official FDA Source

System Notice

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