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The U.S. Food and Drug Administration (FDA) has upgraded a nationwide recall of more than 160,000 bottles of thyroid medication, levothyroxine sodium, after discovering that the medication’s potency falls below approved specifications. This Class II recall involves pills that may not deliver the correct dosage, potentially leaving patients untreated and vulnerable to the harmful effects of hypothyroidism.
The recall first took effect on June 20, 2025, but the FDA elevated it to Class II on July 23, 2025, indicating that the issue could cause medically reversible health effects or persistent but less severe health consequences. This means the risks are moderate but still significant enough to prompt concern.
The recalled drugs were manufactured by Intas Pharmaceuticals, based in India, for Accord Healthcare in the United States. The affected lots include:
Patients taking levothyroxine from any of these lots should stop using the medication and consult their healthcare provider immediately.
Why Subpotent Thyroid Medication Is Dangerous
Levothyroxine sodium is a synthetic form of the thyroid hormone used to treat hypothyroidism. When this hormone is underproduced, the body slows down, causing fatigue, weight gain, depression, slowed heart rate, and cognitive impairment. For patients already struggling with hypothyroidism, taking under-strength medication can mimic or worsen these symptoms.
Long-term under-treatment may result in serious complications, including elevated cholesterol levels, infertility, and heart disease. In vulnerable populations—such as pregnant women, older adults, and those with cardiac conditions—taking ineffective thyroid medication could result in medical emergencies.
The danger is compounded by the fact that the symptoms of subpotent medication may not be immediately noticeable, especially if the change in dosage is subtle. Many patients may continue taking the drug without realizing that their condition is deteriorating.
How to Identify If Your Thyroid Pills Were Recalled
Consumers should check their medication bottles immediately. Look for the brand Accord Healthcare and compare the lot number and expiration date to those listed in the FDA recall.
The label on the prescription bottle should include:
If your medication matches any of the recalled lots, do not stop taking it abruptly. Instead, contact your prescribing doctor to arrange a safe transition to a verified, effective replacement.
Your pharmacy may also be able to assist in identifying whether your prescription is affected. Pharmacists have access to drug lot information and can check their records. If needed, patients should request a new supply from a different batch not affected by the recall.
Legal Rights for Victims Harmed by Defective Thyroid Medication
Patients who suffered adverse health effects due to subpotent thyroid medication may have grounds for a personal injury claim. Pharmaceutical companies have a legal duty to manufacture safe and effective medications that meet FDA standards. When companies fail to comply with these regulations and patients are harmed, those affected can pursue compensation.
Potential damages may include:
If a patient experienced a health crisis, hospitalization, or relapse of hypothyroidism symptoms due to this medication, documentation from medical records will be essential for any legal action. Product liability lawsuits can be filed against the manufacturer, distributor, or other parties involved in the supply chain.
The Importance of Prompt Legal Action
Acting quickly is critical. Statutes of limitations govern how long patients have to file a lawsuit. The clock typically starts ticking from the date of injury or the date the injury is discovered. For cases involving subpotent medication, discovery often occurs after a diagnosis, medical issue, or news of the recall.
Gather any relevant medical records, pharmacy receipts, pill bottles, and correspondence from healthcare providers. These items can help establish a link between the recalled drug and the harm you suffered.
National law firms like Parker Waichman LLP are actively investigating claims involving defective thyroid medications. Their attorneys are prepared to assess your case and guide you through the process of filing a claim.
If you’ve taken levothyroxine sodium from one of the recalled lots and suffered side effects or a worsening medical condition, Parker Waichman LLP can help. Our firm is currently reviewing cases on behalf of patients nationwide who may have been harmed by subpotent thyroid medication. You may be entitled to compensation for medical expenses, lost income, and pain and suffering. Call 1-800-YOUR-LAWYER (1-800-968-7529) now for a free consultation.
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