CLASS I ONGOING Drug recall · Reported 23 Sep 2026 · FDA Enforcement Report
Thyroid Tablets, USP, 1/2 Grain (30 mg) recalled
Vitruvias Therapeutics is recalling Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, distributed nationwide in the US. The recall was initiated on 21 Aug 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0866-2026
- FDA event ID
- 99709
- Recalling firm
- Vitruvias Therapeutics, Auburn, AL
- Brand
- Thyroid
- Manufacturer
- Vitruvias Therapeutics
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Aug 2026
- FDA classified
- 22 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 21 Aug 2026 | Recall initiated by company | |
| 22 Sep 2026 | Classified by FDA | +32 days |
| 23 Sep 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Superpotent Drug
Which lots are affected?
Lot # 504950, Exp Date: 09/30/2026.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Thyroid recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Thyroid recalled by Specialty Process Labs | Specialty Process Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | Thyroid Powder, USP/drum recalled by LGM Pharma | LGM Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain recalled | Humco Holding Group | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain recalled | Humco Holding Group | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain recalled | Humco Holding Group | Manufacturing (CGMP) Deviations | Nationwide |