The most important point: if you take Vitruvias Therapeutics Thyroid Tablets, USP 30 mg, check whether your medication is from lot 504950. Vitruvias voluntarily recalled that one lot because testing confirmed the potential for the tablets to be superpotent. The FDA-posted recall notice specifically tells patients taking tablets from the recalled lot not to stop the medicine on their own; they should contact their healthcare provider for guidance and, if needed, a replacement prescription.
The company announced the recall on August 21, 2026, and the U.S. Food and Drug Administration published it on August 24, 2026. The affected product is Thyroid Tablets, USP 30 mg, NDC 69680-166-00, lot 504950, with an expiration date of September 30, 2026. The recall was to the consumer level and involved product distributed nationwide in the United States. You can review the original FDA-posted recall announcement.
This recall is narrow. It does not cover every thyroid medicine, every strength sold by Vitruvias, or every bottle of Vitruvias Thyroid Tablets. The FDA notice identifies the following product:
| Product | Thyroid Tablets, USP |
|---|---|
| Strength | 30 mg (1/2 grain) |
| NDC | 69680-166-00 |
| Lot | 504950 |
| Expiration date | September 30, 2026 |
| Distribution | Nationwide in the United States to Vitruvias direct accounts |
| Distribution period listed by the recall | January 31, 2025 through September 30, 2025 |
The FDA notice says 3,655 units were released and 1,955 were sold. Those figures describe the recalled lot in the company announcement; they do not tell an individual patient whether a specific bottle is affected.
For another way to identify the 30 mg product, the official DailyMed label lists NDC 69680-166-00 as a 100-tablet bottle. The 30 mg tablet is described as off-white to pale brown, round, flat-faced with a beveled edge, with “THY” debossed on one side and “050” on the other. DailyMed also lists the 30 mg tablet as containing thyroid derived from porcine thyroid glands and providing levothyroxine (T4) and liothyronine (T3). See the official DailyMed labeling.
In this context, “superpotent” means the product may deliver more thyroid-hormone activity than intended. That matters because thyroid replacement is dosed carefully: too much thyroid hormone can push the body toward hyperthyroidism, or an overactive-thyroid state.
The FDA-posted company notice lists possible effects including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate, and heart-rhythm disturbances. Not every person exposed to a recalled tablet will develop symptoms, and the recall announcement does not say that every tablet in the lot has the same degree of excess potency.
As of the August 21 company announcement, Vitruvias reported that it had not received any adverse-event reports known to be related to the recall. That is useful context, but it does not remove the reason for the recall or mean an individual patient should ignore symptoms.
Contact the healthcare professional who manages your thyroid treatment or your pharmacist as soon as practical, and do not make an unsupervised medication change. The recall notice explicitly says patients currently taking Thyroid, USP from lot 504950 should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
A practical way to handle the situation is to have the bottle or pharmacy label in front of you when you call. Give the pharmacist or prescriber the product name, strength, NDC if visible, lot number, expiration date, and the date of your most recent dose. Also mention any new symptoms. This makes it easier for the clinician or pharmacist to decide what information they need next.
If your pharmacy placed the tablets in a prescription vial and the manufacturer lot number is not shown on the patient-facing label, do not guess based on tablet color alone. Ask the dispensing pharmacy to help identify whether your medication came from the recalled lot. Tablet appearance can be a useful cross-check, but the lot number is the key identifier in this recall.
If you have Vitruvias Thyroid Tablets, USP 30 mg but the lot number is not 504950, this specific FDA-posted recall does not identify your lot. You can still ask your pharmacist if you are uncertain, especially if the original bottle is no longer available.
The August 2026 notice is specifically for the 30 mg strength in lot 504950. The DailyMed label shows Vitruvias also marketed 15 mg, 60 mg, 90 mg, and 120 mg strengths, but those strengths are not listed in this particular recall notice.
The recall is important because excess thyroid hormone can affect the heart, nervous system, muscles, and metabolism. Watch for symptoms that are new, clearly worse than usual, or began after taking medicine from the recalled lot. The recall notice names nervousness, heat intolerance, fatigue, muscle weakness, high blood pressure, chest pain, a rapid heart rate, and heart-rhythm problems among the possible effects.
For general emergency guidance, the National Library of Medicine’s MedlinePlus resource on hyperthyroidism advises emergency evaluation for symptoms such as a rapid, irregular heartbeat, dizziness, or a change in consciousness. Its thyroid-hormone information also lists chest pain, rapid or irregular heartbeat, shortness of breath, excessive sweating, and confusion among symptoms associated with excessive thyroid hormone exposure. See MedlinePlus guidance on hyperthyroidism.
If symptoms are severe or feel life-threatening, call 911 or seek emergency care rather than waiting for a routine callback. For less urgent new symptoms, contact the clinician managing your thyroid treatment promptly.
The recall notice specifically highlights older adults, pregnant patients, and infants as groups at greater risk, especially with extended exposure. Vitruvias states that excess thyroid hormone in older adults has been associated with adverse cardiac outcomes; overtreatment during pregnancy has been associated with maternal and fetal complications including premature delivery and low birth weight; and overtreatment in infants may negatively affect growth and development.
These higher-risk groups should not interpret the warning as a reason to abruptly stop thyroid replacement. Hypothyroidism itself can carry significant risks, including during pregnancy and infancy. The recall instructions therefore emphasize contacting a healthcare provider for an individualized plan.
FDA consumer guidance on drug recalls explains that, depending on the recall and the medicine involved, abruptly stopping a medication can sometimes be more harmful than continuing it until a clinician gives specific instructions. FDA advises consumers to follow the recalling company’s directions and to talk with a doctor or pharmacist when they have questions about a recalled drug. See the FDA’s drug recall guidance for consumers.
For this Vitruvias recall, the instruction is unusually clear: patients taking the recalled lot should not discontinue it without first contacting their healthcare provider. A clinician may consider factors such as the patient’s age, pregnancy status, cardiac history, symptoms, treatment goals, current dose, and the availability of a replacement product. Those decisions cannot be made safely from the recall notice alone.
The FDA-posted recall announcement lists Vitruvias Therapeutics at safety@vitruvias.com and (256) 239-9373, Monday through Friday, 9 a.m. to 5 p.m. Central Time, for recall questions. However, the current Vitruvias website, checked September 24, 2026, states that Vitruvias Therapeutics has ceased operations and that its products are now owned and/or distributed by H2-Pharma LLC. Because company contact arrangements can change, your pharmacy is also a useful first point of contact for a recalled prescription.
If you experience a suspected adverse reaction or a product-quality problem, FDA accepts voluntary reports through MedWatch. FDA advises people experiencing an adverse event to contact a healthcare professional first; MedWatch is a safety-reporting system, not a substitute for medical care.
Do not discard the bottle or packaging until you have spoken with the pharmacy or healthcare provider, because the identifying information may be needed to confirm whether the prescription is part of the recall and to arrange the next step.
The Vitruvias Therapeutics thyroid tablet recall is limited to one identified lot: Thyroid Tablets, USP 30 mg, NDC 69680-166-00, lot 504950, expiration September 30, 2026. If your medication matches those details, contact your pharmacist or healthcare provider and follow the recall-specific instruction not to stop treatment on your own. If your strength or lot is different, this particular recall notice does not identify your medication as affected.
Because recall status, company ownership, and distribution details can change, use the FDA notice and your pharmacy as the most current sources for your specific bottle. This article reflects information available from FDA, DailyMed, MedlinePlus, and the Vitruvias website as of September 24, 2026 and is intended for general information, not individualized medical advice.
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