The logo of the US Food and Drug Administration (FDA) is seen on a sign outside the agency's White Oak campus in Silver Spring, Maryland, on July 17, 2025. (Photo by Issam AHMED / AFP) (Photo by ISSAM AHMED/AFP via Getty Images)
The Food and Drug Administration (FDA) has elevated the recall status of a widely used thyroid medication due to concerns over its effectiveness. On October 6, 2023, the agency announced a Class II recall for approximately 54,432 bottles of levothyroxine sodium tablets. The recall stems from reports indicating that these tablets may not contain the appropriate potency required for therapeutic effect.
This specific medication is available by prescription only and is packaged in bottles containing 90 tablets each, with a dosage of 88 mcg (0.088 milligrams). The recall affects products distributed by Accord Healthcare Inc., headquartered in Raleigh, North Carolina, and manufactured by Intas Pharmaceuticals Ltd., based in India. The FDA indicated that the recall was initiated voluntarily by the manufacturer in response to the findings.
Potential Risks Associated with Sub-Potency
Patients relying on levothyroxine sodium for thyroid hormone replacement therapy may face significant health risks if the medication does not meet the prescribed potency. Insufficient levels of this hormone can lead to symptoms of hypothyroidism, including fatigue, weight gain, and depression. The FDA urges consumers and healthcare professionals to remain vigilant and check their medication supplies.
As part of the recall process, healthcare providers and pharmacies are being advised to review their inventory and remove any affected bottles from circulation. Patients who have these medications are encouraged to consult their healthcare providers for guidance on alternative options and to address any health concerns that may arise from discontinuing use of the affected product.
Next Steps for Affected Patients
Individuals who have purchased the recalled levothyroxine sodium tablets are advised to return them to the place of purchase for a full refund. Additionally, it is crucial for patients to seek medical advice if they experience any adverse effects or if they are concerned about their thyroid treatment.
The FDA continues to monitor the situation closely and urges any patients affected by the recall to report any side effects or quality issues to the agency. As always, maintaining effective communication between patients and healthcare providers is essential for ensuring safety and health in medication management.
For more information regarding the recall, individuals can visit the FDA’s official website, where updates and specific details about the affected products are being regularly posted.
