FDA elevates thyroid tablet recall to most serious level

Live updates

1. 5d ago

   FDA Class I recall for Vitruvias Therapeutics thyroid tablets

   The FDA has issued a Class I recall for Vitruvias Therapeutics Thyroid Tablets USP 30 mg, lot 504950. This most severe recall category applies to product NDC 69680-166-00 with an expiration date of September 30, 2026. The agency identified superpotent dosing in this batch, which creates a risk of hyperthyroidism for patients. While the recall is active, no adverse events have been reported. Patients using this specific lot should check their medication against official FDA records.

   Why it matters

   Class I recalls occur when there is a reasonable probability that use of a product will cause serious adverse health consequences or death. Hyperthyroidism results from excessive thyroid hormone levels in the body.

   What is confirmed

   • The FDA escalated the recall of Vitruvias Therapeutics thyroid tablets to Class I.
   • The recall affects lot 504950 of Thyroid Tablets USP 30 mg, NDC 69680-166-00.
   • The affected tablets have an expiration date of September 30, 2026.
   • Superpotent dosing in this batch carries a risk of inducing hyperthyroidism.
   • No adverse events tied to this medication batch have been documented to date.

   What to watch next

   • Reports of adverse events in the FDA Adverse Event Monitoring System
   • Updates on the recall status of other Vitruvias Therapeutics lots
   Sources used for this update (4)

   1. www.recalledornot.com — Latest product recalls - Recalled or Not?
   2. www.fda.gov — FDA Adverse Event Monitoring System (AEMS)
   3. rxrecalls.com — Check if your medication has been recalled | RxRecalls
   4. www.fda.gov — FDA Adverse Event Monitoring System (AEMS) Latest Quarterly ...
   confidence 100%
2. 7d ago

   FDA Classifies Vitruvias Thyroid Tablet Recall as Most Serious Level

   The Food and Drug Administration has escalated the recall of Vitruvias Therapeutics thyroid tablets to a Class I recall, the agency's most severe category. The action targets lot 504950 of Thyroid Tablets USP 30 mg, identified by NDC 69680-166-00 and an expiration date of September 30, 2026. The affected products feature superpotent dosing that carries a risk of inducing hyperthyroidism in patients. No adverse events tied to this medication batch have been documented to date.

   Why it matters

   Class I recalls are reserved for situations where exposure to a defective product is likely to cause serious adverse health consequences or death. Superpotent thyroid hormones can cause acute symptoms of excessive thyroid activity, including rapid heart rate, weight loss, and tremors. Regulatory oversight remains focused on removing these medications from circulation before patients experience medical harm.

   What is confirmed

   • Vitruvias Therapeutics is recalling lot 504950 of Thyroid Tablets USP 30 mg with NDC 69680-166-00.
   • A total of 3,655 bottles of the affected thyroid tablets were distributed between January 31 and September 30, 2025.
   • The FDA designated the recall as a Class I status due to superpotent tablets that can cause hyperthyroidism.

   What to watch next

   • Reports of any adverse medical events linked to the superpotent tablets
   • Further distribution updates from Vitruvias Therapeutics or the FDA regarding the remaining unrecovered bottles
   Sources used for this update (3)

   1. www.karmactive.com — Thyroid tablet recall: Vitruvias Therapeutics pulls ...
   2. www.research.va.gov — VA Research News Briefs
   3. economictimes.indiatimes.com — fda drug recall: Latest News & Videos, Photos about fda drug ...
   confidence 100%
3. 13d ago

   FDA elevates thyroid tablet recall to Class I

   The FDA has designated the recall of Vitruvias Therapeutics thyroid tablets as a Class I recall, the most serious level, due to superpotent 30 milligram tablets that can cause hyperthyroidism. The recall affects nearly 16,000 bottles nationwide, specifically lot 504950 with NDC 69680-166-00 and an expiration date of September 30, 2026. No known adverse events have been reported to date.

   Why it matters

   The FDA's classification of this recall as Class I indicates a reasonable probability that use of the product will cause serious adverse health consequences. Thyroid tablets are used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. The recall was initiated after the medicine was found to be potentially 'superpotent,' which can lead to serious health effects including chest pain, high blood pressure, and irregular heartbeats.

   What is confirmed

   • The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs.
   • The recall affects nearly 16,000 bottles nationwide, specifically lot 504950 with NDC 69680-166-00 and an expiration date of September 30, 2026.
   • The FDA has classified the recall of Vitruvias Therapeutics thyroid tablets as a Class I recall.

   What to watch next

   • Further updates on adverse events related to the recalled thyroid tablets
   • Actions taken by Vitruvias Therapeutics in response to the recall
   • FDA's ongoing evaluation of the recall and its impact on public health
   Sources used for this update (10)

   1. www.fda.gov — U.S. Food and Drug Administration
   2. www.fda.gov — Drugs | FDA
   3. en.wikipedia.org — Food and Drug Administration - Wikipedia
   4. www.usa.gov — Food and Drug Administration (FDA) | USAGov
   5. www.fda.gov — Food | FDA
   6. www.fda.gov — Drug Approvals and Databases | FDA
   7. recalldirectory.com — FDA Class I Recalls - Recall Directory
   8. health.yahoo.com — What To Know Before Asking Your Doctor About Hormone Replacement Therapy For Menopause Mood Swings - Yahoo Health
   9. economictimes.indiatimes.com — adverse drug reactions News and Updates from The Economic ...
   10. www.fda.gov — Recalls - Health Fraud | FDA
   confidence 100%
4. 19d ago

   FDA assigns Class I status to Vitruvias thyroid tablet recall

   The FDA has designated the recall of Vitruvias Therapeutics thyroid tablets as a Class I recall, the most serious level. This ongoing action targets superpotent 30 milligram tablets, specifically lot 504950 with NDC 69680-166-00 and an expiration date of September 30, 2026. Superpotent medication can cause hyperthyroidism, leading to chest pain, high blood pressure, and irregular heartbeats. While the recall affects nearly 16,000 bottles nationwide, the company has reported no known adverse events to date.

   Why it matters

   Class I recalls occur when there is a reasonable probability that use of a product will cause serious adverse health consequences or death. These tablets are intended to manage thyroid hormone levels, and superpotency can push patients into a dangerous hyperthyroid state.

   What is confirmed

   • The FDA designated the recall of Vitruvias Therapeutics thyroid tablets as a Class I recall under notice D-0866-2026.
   • The recall involves nearly 16,000 bottles of the medication nationwide.
   • The affected product is lot 504950 of 30 milligram Thyroid Tablets, USP, with NDC 69680-166-00.
   • The affected tablets have an expiration date of September 30, 2026.

   Still unconfirmed

   • Pfizer is responsible for the recall of nearly 16,000 bottles of the thyroid drug.

   What to watch next

   • Reports of adverse events resulting from the superpotent tablets
   • FDA notification regarding the closure of recall D-0866-2026
   Sources used for this update (5)

   1. www.regdatalab.com — FDA Recall Statistics 2026 — RegDataLab
   2. www.theepochtimes.com — Nearly 16,000 Bottles of Popular Thyroid Drug Recalled Nationwide | The Epoch Times
   3. methamphetaminebox.com — Adderall For Sale Online | Buy Adderall On The Dark Web | Adderall For Sale Overnight
   4. freshrecalls.com — D-0866-2026 Recall: VITRUVIAS THERAPEUTICS | Fresh Recalls
   5. www.ntd.com — Pfizer Recalls Nearly 16,000 Bottles of Thyroid Drug Over ...
   confidence 90%
5. 22d ago

   FDA elevates recall of superpotent Vitruvias thyroid tablets

   Vitruvias Therapeutics is voluntarily recalling lot 504950 of its 30 milligram Thyroid Tablets, United States Pharmacopeia, due to superpotency. The nationwide consumer-level recall affects product with National Drug Code 69680-166-00 and an expiration date of September 30, 2026. Superpotent medication may deliver hormone levels exceeding label claims, potentially inducing hyperthyroidism. This condition can cause muscle weakness, high blood pressure, chest pain, and irregular or fast heartbeats. The company reports no known adverse events as of the notice date.

   Why it matters

   The FDA manages drug recalls across three classes based on the severity of health risks. This specific action targets a medication that regulates thyroid hormone levels. Incorrect dosing in thyroid treatments can lead to systemic cardiovascular and metabolic instability.

   What is confirmed

   • Vitruvias Therapeutics is recalling lot 504950 of its Thyroid Tablets, United States Pharmacopeia 30 milligrams.
   • The recall covers National Drug Code 69680-166-00 with an expiration date of September 30, 2026.
   • Superpotent medication can trigger hyperthyroidism, resulting in chest pain, high blood pressure, fast or irregular heartbeat, and muscle weakness.
   • The FDA describes the recall as voluntary and at the consumer level.

   Still unconfirmed

   • There have been no known adverse events tied to this recall as of the notice date.

   What to watch next

   • Reports of adverse patient reactions to lot 504950
   • FDA reclassification of the recall's risk level
   • Company statements regarding the cause of the superpotency
   Sources used for this update (4)

   1. www.cpsc.gov — Recalls & Product Safety Warnings | CPSC.gov
   2. www.fda.gov — Drug Alerts and Statements | FDA
   3. medivascan.com — Drug recalls, by class and condition - MedivaScan
   4. vitalnews.org — Nationwide Pill Recall Sparks Heart Risk Fears | Vital News
   confidence 90%
6. 24d ago

   FDA Clears Lilly Thyroid Cancer Drug Retevmo

   The United States Food and Drug Administration has granted approval to Eli Lilly's selpercatinib, marketed as Retevmo, for treating RET-positive thyroid tumours, giving the drug a market advantage over rival therapies. Meanwhile, regulatory actions continue to impact products related to thyroid health, including a separate high-risk escalation for a medication recall involving superpotent tablets distributed nationwide. Patients utilizing thyroid treatments face ongoing updates regarding agency classifications, batch details, and safety instructions. Regulatory developments concurrently shape the competitive market for advanced oncology treatments targeting specific genetic mutations in thyroid cancer patients.

   Why it matters

   Thyroid treatments span both chronic hormone management and targeted oncology drugs for specific genetic mutations. The regulatory environment demands strict adherence to potency standards while simultaneously approving advanced therapies for cancer patients. These parallel regulatory tracks affect drug availability and treatment options for individuals managing thyroid conditions.

   What is confirmed

   • The FDA grants approval to Eli Lilly's RET inhibitor selpercatinib as Retevmo for RET-positive lung and thyroid tumours.

   Still unconfirmed

   • Vitruvias Therapeutics Inc. recalled one lot of Thyroid Tablets, USP 30 mg, after testing revealed the medication could be stronger than intended.

   What to watch next

   • Further updates from the FDA regarding batch details and instructions for the recalled thyroid tablets.
   • Additional market competition data between Retevmo and rival therapies for thyroid cancer.
   Sources used for this update (4)

   1. www.wamwamfm.com — FDA Elevates Broccoli Recall to Highest Risk Level
   2. pharmaphorum.com — Roche, Blueprint raise pressure on Lilly with new Gavreto ...
   3. economictimes.indiatimes.com — thyroid health: Latest News & Videos, Photos about thyroid ...
   4. pharmaphorum.com — FDA clears Lilly’s Retevmo for RET-positive lung, thyroid ...
   confidence 80%
7. 27d ago

   FDA Classifies Thyroid Tablet Recall at Highest Risk Level

   Vitruvias Therapeutics Inc. has recalled one lot of its Thyroid Tablets, USP 30 mg, after testing revealed the medication could be stronger than intended. The United States Food and Drug Administration has elevated the action to its highest risk classification, prompting concern and confusion among Americans who rely on the treatment to manage thyroid conditions. The affected recall involves thousands of units distributed nationwide. Patients are advised to consult official agency guidance regarding batch details and instructions to mitigate severe health risks associated with superpotent medication.

   Why it matters

   Thyroid medications are critical for patients managing hormonal conditions, meaning unexpected variations in potency can lead to severe adverse health consequences. The recall affects a significant distribution volume across the United States. Regulatory classifications of this severity signal that the federal agency views the product defect as a serious threat to consumer safety.

   What is confirmed

   • Vitruvias Therapeutics Inc. recalled one lot of Thyroid Tablets, USP 30 mg.
   • The recall involves thousands of units distributed nationwide.
   • The FDA classified the recall at its highest risk level due to superpotency issues.

   What to watch next

   • Additional lot recalls or expansions by Vitruvias Therapeutics Inc.
   • Specific batch numbers and instructions released by regulatory agencies for consumers
   Sources used for this update (5)

   1. economictimes.indiatimes.com — consumer product recall News and Updates from The Economic ...
   2. www.accessdata.fda.gov — Medical Device Recalls - accessdata.fda.gov
   3. www.centraloregondaily.com — Thyroid medicine recall sparks concern, confusion. Here's ...
   4. economictimes.indiatimes.com — fda alert: Latest News & Videos, Photos about fda alert | The ...
   5. www.marketbeat.com — Pulse Biosciences (PLSE) FDA Approvals, PDUFA Dates & Drug ...
   confidence 100%
8. 32d ago

   FDA elevates thyroid tablet recall to Class I risk level

   The US FDA has reclassified a recall of Vitruvias Therapeutics' thyroid tablets to a Class I risk level due to superpotency issues, posing serious adverse health consequences or death. Affected tablets are stronger than expected. Patients should check official agency guidance for batch details and instructions.

   Why it matters

   The recall affects thyroid tablets used to treat hypothyroidism. The FDA's reclassification indicates a high risk of serious harm or death. This recall is part of broader quality control issues with Indian pharmaceutical companies.

   What is confirmed

   • The FDA reclassified a recall of Vitruvias Therapeutics' thyroid tablets to a Class I risk level.
   • The affected tablets are stronger than expected, posing a risk of serious adverse health consequences or death.
   • Indian Pharma Giants will recall medicines in the US over quality flaws.

   Still unconfirmed

   • Dr Reddy's Laboratories underwent a Pre-Approval Inspection by the US health regulator at their FTO-11 manufacturing unit from October 5-7.

   What to watch next

   • Further updates on the recall and affected batches
   • Investigation into quality control issues with Indian pharmaceutical companies
   • FDA's actions against Vitruvias Therapeutics and other companies involved
   Sources used for this update (3)

   1. indiawest.com — FDA: Indian Pharma Giants Will Recall Medicines In US Over Quality ...
   2. www.pharmpix.com — FDA Drug Recall: Thyroid Tablets USP 30 mg - pharmpix.com
   3. economictimes.indiatimes.com — food and drug administration fda: Latest News & Videos ...
   confidence 95%
9. 34d ago

   FDA Elevates Thyroid Tablet Recall to Class I Risk Level

   The FDA has reclassified a recall of Vitruvias Therapeutics' thyroid tablets to a Class I risk level due to superpotency issues. The affected tablets are stronger than expected, posing a risk of serious adverse health consequences or death. Patients using the medication should check official agency guidance for batch details and instructions.

   Why it matters

   The recall was initially made several weeks ago for one lot of the medication. A Class I classification signifies a reasonable probability of serious harm or death from exposure to the violative product. This classification is the most serious level of recall.

   What is confirmed

   • The FDA classified Vitruvias Thyroid Tablets USP 30 mg lot 504950 as Class I after a superpotency recall linked to excess thyroid-hormone exposure.
   • A Class I classification signifies a reasonable probability that exposure to the violative product will cause serious adverse health consequences or death.
   • The affected tablets are superpotent and stronger than expected.

   What to watch next

   • Further updates on the recall and any additional lots affected
   • Reports of adverse reactions or health consequences from the superpotent tablets
   • Guidance from Vitruvias Therapeutics and the FDA on safe usage and replacement of the recalled medication
   Sources used for this update (8)

   1. www.fda.gov — Medical Device Recalls and Early Alerts | FDA
   2. www.healthline.com — FDA Issues Class II Blood Pressure Medication Recall, Over 13,000 Bottles Affected
   3. recallnow.org — RecallNow | Check if a product has been recalled
   4. medicaltoxic.com — FDA Classifies Superpotent Thyroid Tablet Recall as Class I
   5. medlifeguide.com — Vitruvias Therapeutics Thyroid Recall Guide 2026
   6. www.accessdata.fda.gov — Medical Device Recalls - Food and Drug Administration
   7. drugrecallcheck.com — Check if your medication has been recalled | US Drug Recall ...
   8. economictimes.indiatimes.com — fda recall of atorvastatin calcium tablets: Latest News ...
   confidence 92%
10. 41d ago

    FDA Upgrades Thyroid Tablet Recall to Highest Risk Level

    The Food and Drug Administration has reclassified a medication recall for thyroid tablets to a Class I risk level. Vitruvias Therapeutics originally recalled one lot of the medication several weeks ago because of a potency issue. The company stated that the affected tablets are superpotent and stronger than expected. A Class I classification signifies a reasonable probability that exposure to the violative product will cause serious adverse health consequences or death. Patients utilizing the medication should check official agency guidance for batch details and instructions.

    Why it matters

    Class I risk level classifications are the most serious warnings issued by federal regulators. They indicate a strong risk of severe health complications or death from the product. Consumers relying on thyroid medication need precise batch information to avoid dangerous potency levels.

    What is confirmed

    • The Food and Drug Administration reclassified the recall of the product to Class I this week.

    What to watch next

    • Official agency guidance regarding specific batch details and instructions for patients using the medication.
    Sources used for this update (3)

    1. www.usatoday.com — Thyroid medicine recall receives FDA's highest risk level
    2. www.yahoo.com — FDA elevates thyroid tablet recall to most serious level - Yahoo
    3. www.yahoo.com — Over 1.1M people using GLP-1 drugs without FDA-approved reason
    confidence 100%
11. 43d ago

    FDA Upgrades Thyroid Tablet Recall to Highest Risk Level

    The Food and Drug Administration has elevated a medication recall for thyroid tablets to a Class I risk level. Vitruvias Therapeutics originally recalled one lot of the medication several weeks ago because of a potency issue. The company stated that the affected tablets are superpotent and stronger than expected. A Class I classification signifies a reasonable probability that exposure to the violative product will cause serious adverse health consequences or death. Patients utilizing the medication should check official agency guidance for batch details and instructions.

    Why it matters

    Class I designations represent the most urgent safety category issued by federal regulators. Drug potency issues can lead to unexpected medical complications for patients relying on steady hormonal treatment. The safety action highlights regulatory oversight of pharmaceutical manufacturing defects.

    What is confirmed

    • The Food and Drug Administration raised a recall for thyroid tablets to Class I, its most serious risk level.
    • Vitruvias Therapeutics recalled one lot of thyroid tablets because of a potency issue several weeks ago.
    • The recalled tablets from Vitruvias Therapeutics, Inc. are superpotent and stronger than expected.
    • A Class I risk rating means there is a reasonable probability that exposure to a violative product will cause serious adverse health consequences or death.

    What to watch next

    • Specific batch numbers and safety instructions released by the FDA for affected patients
    • Further statements from Vitruvias Therapeutics regarding the manufacturing cause of the superpotency issue
    Sources used for this update (7)

    1. www.theepochtimes.com — FDA Raises Thyroid Tablet Recall to Most Serious Level Over Superpotency Issue | The Epoch Times
    2. www.yahoo.com — Thyroid Medication Recall Elevated to Highest Warning Level: FDA
    3. www.zerohedge.com — FDA Raises Thyroid Tablet Recall To Most Serious Level | ZeroHedge
    4. www.healthandme.com — Thyroid Medicine Recall Gets US FDA’s Highest Risk Rating: What To Know | Health and Me
    5. www.yahoo.com — Raw milk cheese recalled over E. coli outbreak, FDA says
    6. economictimes.indiatimes.com — Ahead of Market: 10 things that will decide stock market action on Friday
    7. economictimes.indiatimes.com — McDonald’s latest news: McDonald’s is spending $8.5 billion on changes: AI drive-thru, automated kitc....
    confidence 100%
12. 45d ago

    FDA Elevates Thyroid Medication Recall to Class I Risk Level

    The FDA has upgraded a recall for thyroid medication to its most serious risk level. This classification, known as Class I, indicates the highest level of urgency for the drug recall. Multiple reports confirm the agency now views the situation as the most serious or urgent category available for such actions. Patients using the affected thyroid tablets should monitor official FDA guidance for specific batch information and safety instructions.

    Why it matters

    Class I recalls are reserved for situations where there is a reasonable probability that use of a product will cause serious adverse health consequences or death. Thyroid medications are critical for regulating metabolism and hormone levels. An upgrade in risk level typically triggers more aggressive notification and recovery efforts.

    What is confirmed

    • The FDA elevated a thyroid tablet recall to its most serious risk level.
    • The recall is classified as a Class I risk level.

    What to watch next

    • FDA release of specific lot numbers and affected tablet batches
    • Public health advisories regarding patient symptoms or risks
    • Manufacturer statements on the cause of the recall
    Sources used for this update (4)

    1. NewsNation — FDA elevates thyroid tablet recall to most serious level
    2. USA Today — Thyroid medicine recall receives FDA's highest risk level
    3. FOX 8 News — Thyroid medication recall classified as FDA’s most urgent
    4. SuaraGarut.ID — FDA Upgrades Thyroid Drug Recall to Class I Risk Level
    confidence 100%