FDA Drug Recall Alert – One Lot of Thyroid Tablets, USP 30 mg
| Date: | August 31, 2026 |
| From: | Health Plan of San Joaquin/Mountain Valley Health Plan (“Health Plan”) |
| To: | Health Plan Practitioners, Facilities, and Hospitals |
| Type: | Informational/Educational |
| Subject: | FDA Drug Recall Alert – One Lot of Thyroid Tablets, USP 30 mg |
| Business: | Medi-Cal Managed Care/Medicare Advantage D-SNP |
On August 24, 2026, the Food and Drug Administration (FDA) released a recall announcement on one lot (Lot. No. 504950) of Thyroid Tablets, USP 30 mg.
This is for informational purposes only. You may or may not have administered the medication. Please disregard if you have not been affected by this recall.
For the complete details regarding this recall announcement, please visit the following web link: 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#recall-announcement
Vitruvias Therapeutics, Inc Issues Nationwide Recall of One Lot of Thyroid Tablets, USP 30 mg Due to Potential Super Potency
Company Announcement: AUBURN, Ala. (August 21, 2026) – Vitruvias Therapeutics Inc. is voluntarily recalling one lot (Lot. No. 504950) of Thyroid Tablets, USP 30 mg to the consumer level. The product is being recalled because testing confirmed the potential for the product to be superpotent.
Risk Statement: Consumption of superpotent Thyroid tablets can cause hyperthyroidism (overactive thyroid) including, but not limited to, weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. The patient population at greater risk from superpotent thyroid are elderly, pregnant women, and infants, especially over extended periods of time. Excess levels of thyroid hormones in the elderly have been associated with adverse outcomes, particularly to cardiac health. Overtreatment of hypothyroidism in pregnancy is associated with a higher rate of maternal and fetal complications, including premature delivery and low birth weight. Overtreatment of hypothyroidism in infants may have negative effects on growth and development. To date, Vitruvias Therapeutics has not received any reports of adverse events known to be related to this recall.
To best identify the product, the NDC, Product Description, Lot Number, and Expiration Date are listed below.
| Product | NDC | Lot | Exp Date | Units Released | Units Sold | First Distribution Date | Last Distribution Date |
|---|---|---|---|---|---|---|---|
| Thyroid Tablets, USP 30 mg | 69680-01 66-00 | 504950 | 9/30/2026 | 3,655 | 1955 | 1/31/2025 | 9/30/2025 |
Lot 504950 was distributed nationwide in the USA to Vitruvias Therapeutics’ direct accounts from Jan. 31, 2025 to Sept. 30, 2025.
What to do: Vitruvias Therapeutics is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for destruction of all recalled product. Patients who are currently taking Thyroid, USP from Lot 504950, which is being recalled, should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
Consumers with questions about the recall can contact Vitruvias Therapeutics, Inc. by email at safety@vitruvias.com or by phone at (256) 239-9373 Monday through Friday from 9 a.m. to 5 p.m. CT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Contact Information:
Consumers:
Roger Graben
(256) 239-9373
safety@vitruvias.com
If you have any further questions, please contact your Provider Services Representative, or call our Customer Service Department at 1-888-936-PLAN (7526). You may also visit https://www.hpsj.com/alerts/ for online access to the documents shared. The most recent information about Health Plan and our services is always available on our website www.hpsj-mvhp.org
