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Shedding Light on the Risks
& Benefits of Medications FDA Recalls and Warnings: Levothyroxine and Natural Thyroid Drugs Recalled for Potency Problems
Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
August 25, 2026
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Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting drug recalls for levothyroxine and Thyroid Tablets (natural). This installment also features an FDA warning letter issued to Intas Pharmaceuticals (a manufacturer of levothyroxine) for violations at its manufacturing facility.
The levothyroxine recall is a nationwide Class II recall, while the Thyroid Tablets recall has not yet been classified. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or for which the likelihood of serious adverse health consequences is considered remote.
Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall.
How to Read This Report
The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”
While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.
- Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
- Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
- Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.
Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.
Drug Recalls
Levothyroxine Sodium Tablets (generic for Synthroid)
Company: Accord Healthcare
Manufacturing Location: Selaqui, Dehradun, India, by Intas Pharmaceuticals Limited
Scope: Unspecified quantity of 90-count and 1,000-count bottles of tablets ranging from 25 mcg (0.025 mg) to 300 mcg (0.3 mg)
Drug Purpose: Thyroid-hormone replacement therapy that is used to treat hypothyroidism.
Recall Reason: Subpotent drug; the amount of active ingredient was less than the allowable range, potentially reducing drug effectiveness.
Recall Initiation Date: August 6, 2026
Recall Level: Class II
Essential Extras: Accord also recalled levothyroxine tablets in July 2026, September 2025, and June 2025. Accord’s manufacturer, Intas Pharmaceuticals, was last inspected by the FDA in September 2025 and received a follow-up warning letter in March 2026. (See facility inspection warning letter summary below)
Link: FDA Enforcement Report
Thyroid Tablets (Levothyroxine and Liothyronine)
Company: Vitruvias Therapeutics, Inc.
Manufacturing Location: Not provided
Scope: 3,655 units (one lot) of 30 mg natural desiccated thyroid tablets distributed nationwide
Drug Purpose: Natural thyroid replacement derived from porcine (pig) thyroid glands used to treat underactive thyroid (hypothyroidism).
Recall Reason: The tablets may be superpotent, meaning they contain too much of the active ingredient. Excess thyroid hormone can cause symptoms of hyperthyroidism, including a rapid or abnormal heart rate, chest pain, high blood pressure, nervousness, fatigue, heat intolerance, and weight loss.
Essential Extras: Unlike levothyroxine (the generic for Synthroid), which is a synthetic version of the hormone used to treat an underactive thyroid, natural thyroid replacement medications like Vitruvias’ Thyroid tablets are not FDA-approved. The medication is used by people who don’t respond well to the synthetic formulations.
The FDA has raised concerns about the safety and effectiveness of unapproved animal-derived thyroid medications because they have not undergone FDA review to ensure their safety, purity, and potency. The agency is working to establish an approval pathway for these products and plans to issue draft guidance for manufacturers.
Recall Level: Not yet classified, but likely to be a Class I Recall due to potential health risk.
Recall Initiation Date: August 21, 2026
Link: FDA Press Release
Inspection Facility Warning Letter to Intas Pharmaceuticals
Intas Pharmaceuticals Limited
Type: Drug Manufacturer
FDA Department issuing Warning: Center for Drug Evaluation and Research (CDER)
Warning Letter Date: March 30, 2026
Facility Location: Camp Road, Selaqui, Dehradun, India
Date(s) of Inspections: September 8 to September 17, 2025
FDA Warning: Intas’s quality unit did not adequately ensure its drugs met Current Good Manufacturing Practice (CGMP) requirements. Intas did not adequately investigate out-of-specification stability results for certain tablet products, including subpotent assay results that continued despite multiple corrective actions. Although the facility shortened product expiration periods and recalled certain affected batches, the FDA said it did not sufficiently determine the root cause, assess all potentially affected lots, evaluate its analytical method, or review possible links to complaints and adverse events.
Intas was required to respond to the FDA within 15 working days, detailing its corrective actions. As of August 2026, the FDA has not publicly issued a closeout letter or announced a subsequent reinspection of the facility. The agency said unresolved violations could result in withheld drug approvals or in the refusal of products manufactured at the facility to enter the United States.
Link: FDA Warning Letter
Read the warning letter for a complete description of violations.
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<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting drug recalls for levothyroxine and Thyroid Tablets (natural). This installment also features an FDA warning letter issued to Intas Pharmaceuticals (a manufacturer of levothyroxine) for violations at its manufacturing facility.</p>
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<p>The levothyroxine recall is a nationwide Class II recall, while the Thyroid Tablets recall has not yet been classified. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or for which the likelihood of serious adverse health consequences is considered remote.</p>
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<p>Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall.</p>
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<h2 class="wp-block-heading">How to Read This Report</h2>
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<h3 class="wp-block-accordion-heading has-icon has-icon-right"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Recalls (Enforcement Reports Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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<div role="region" class="wp-block-accordion-panel"><!-- wp:paragraph -->
<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or "not yet classified."</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
<!-- /wp:paragraph --><!-- wp:list -->
<ul class="wp-block-list"><!-- wp:list-item -->
<li>Class I recalls are the most serious. In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death."</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<h3 class="wp-block-accordion-heading has-icon has-icon-right"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Warning Letters (Warning Letters Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
<!-- /wp:accordion-heading --><!-- wp:accordion-panel -->
<div role="region" class="wp-block-accordion-panel"><!-- wp:paragraph -->
<p>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.</p>
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<h3 class="wp-block-accordion-heading has-icon has-icon-right"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Drug Imports Alerts Database</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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<div role="region" class="wp-block-accordion-panel"><!-- wp:paragraph -->
<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99">unapproved new drugs</a>. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.</p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
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<h3 class="wp-block-heading">Levothyroxine Sodium Tablets (generic for Synthroid)</h3>
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<p><strong>Company</strong>: Accord Healthcare <br><strong>Manufacturing Location</strong>: Selaqui, Dehradun, India, by Intas Pharmaceuticals Limited<br><strong>Scope</strong>: Unspecified quantity of 90-count and 1,000-count bottles of tablets ranging from 25 mcg (0.025 mg) to 300 mcg (0.3 mg)<br><strong>Drug Purpose</strong>: Thyroid-hormone replacement therapy that is used to treat hypothyroidism.<br><strong>Recall Reason</strong>: Subpotent drug; the amount of active ingredient was less than the allowable range, potentially reducing drug effectiveness. <br><strong>Recall Initiation Date:</strong> August 6, 2026 <br><strong>Recall Level:</strong> Class II<br><strong>Essential Extras</strong>: Accord also recalled levothyroxine tablets in <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99194">July 2026</a>, <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97613">September 2025</a>, and <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97103">June 2025</a>. Accord’s manufacturer, Intas Pharmaceuticals, was last inspected by the FDA in September 2025 and received a <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026">follow-up warning letter</a> in March 2026. (See facility inspection warning letter summary below)<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99584">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Thyroid Tablets (Levothyroxine and Liothyronine)</h3>
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<p><strong>Company</strong>: Vitruvias Therapeutics, Inc. <br><strong>Manufacturing Location</strong>: Not provided <br><strong>Scope</strong>: 3,655 units (one lot) of 30 mg natural desiccated thyroid tablets distributed nationwide<br><strong>Drug Purpose</strong>: Natural thyroid replacement derived from porcine (pig) thyroid glands used to treat underactive thyroid (hypothyroidism).<br><strong>Recall Reason</strong>: The tablets may be superpotent, meaning they contain too much of the active ingredient. Excess thyroid hormone can cause symptoms of hyperthyroidism, including a rapid or abnormal heart rate, chest pain, high blood pressure, nervousness, fatigue, heat intolerance, and weight loss.<br><strong>Essential Extras</strong>: Unlike levothyroxine (the generic for Synthroid), which is a synthetic version of the hormone used to treat an underactive thyroid, natural thyroid replacement medications like Vitruvias’ Thyroid tablets are not FDA-approved. The medication is used by people who don’t respond well to the synthetic formulations.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>The FDA has raised concerns about the safety and effectiveness of unapproved animal-derived thyroid medications because they have not undergone FDA review to ensure their safety, purity, and potency. The agency is working to establish an approval pathway for these products and plans to issue <a href="https://www.fda.gov/drugs/enforcement-activities-fda/fdas-actions-address-unapproved-thyroid-medications">draft guidance</a> for manufacturers.<br><br><strong>Recall Level</strong>: Not yet classified, but likely to be a Class I Recall due to potential health risk.<br><strong>Recall Initiation Date</strong>: August 21, 2026 <br><strong>Link</strong>: <a href="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">FDA Press Release</a> </p>
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<h2 class="wp-block-heading">Inspection Facility Warning Letter to Intas Pharmaceuticals</h2>
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<h3 class="wp-block-heading">Intas Pharmaceuticals Limited </h3>
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<p><strong>Type</strong>: Drug Manufacturer <br><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER) <br><strong>Warning Letter Date</strong>: March 30, 2026 <br><strong>Facility Location</strong>: Camp Road, Selaqui, Dehradun, India <br><strong>Date(s) of Inspections</strong>: September 8 to September 17, 2025 <br><strong>FDA Warning</strong>: Intas’s quality unit did not adequately ensure its drugs met Current Good Manufacturing Practice (CGMP) requirements. Intas did not adequately investigate out-of-specification stability results for certain tablet products, including subpotent assay results that continued despite multiple corrective actions. Although the facility shortened product expiration periods and recalled certain affected batches, the FDA said it did not sufficiently determine the root cause, assess all potentially affected lots, evaluate its analytical method, or review possible links to complaints and adverse events. </p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Intas was required to respond to the FDA within 15 working days, detailing its corrective actions. As of August 2026, the FDA has not publicly issued a closeout letter or announced a subsequent reinspection of the facility. The agency said unresolved violations could result in withheld drug approvals or in the refusal of products manufactured at the facility to enter the United States.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026">FDA Warning Letter<br></a>Read the warning letter for a complete description of violations.</p>
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