The Food and Drug Administration (FDA) has expanded the recall of over 54,000 bottles of a widely prescribed thyroid medication due to concerns over their potency. The agency upgraded the recall of 54,432 bottles of levothyroxine sodium tablets to Class II on October 6, 2023. This action indicates that the medication may not meet the required strength, potentially impacting patient health.
The recalled levothyroxine sodium tablets are available in doses of 88 mcg (0.088 milligrams) and are packaged in bottles containing 90 tablets each. The recall was initiated by Accord Healthcare Inc., based in Raleigh, North Carolina, which distributed the product manufactured by Intas Pharmaceuticals Ltd., a company located in India.
According to the FDA notice, the recall was voluntarily initiated by Accord Healthcare after discovering the medications may have lower potency than specified. The agency emphasizes that while these tablets are prescribed to manage thyroid hormone levels, patients using the affected medication should consult their healthcare provider to ensure they are receiving the appropriate treatment.
Levothyroxine is a critical medication for individuals with hypothyroidism, a condition where the thyroid gland does not produce enough hormones. Inadequate treatment can lead to serious health issues, including fatigue, weight gain, and depression. The FDA’s decision to elevate the recall status to Class II reflects the potential for adverse health consequences, although it does not indicate a life-threatening situation.
Patients are advised to check their medication bottles for the affected lot numbers and to return any recalled products to their pharmacy. Additionally, the FDA encourages consumers to report any adverse effects or quality issues related to the recalled medication through its MedWatch program.
As the situation develops, healthcare professionals and patients alike will be monitoring updates from the FDA and Accord Healthcare. The agency remains committed to ensuring the safety and efficacy of medications available to the public and urges vigilance regarding prescription medications.
