The U.S. Food and Drug Administration (FDA) has announced a recall of more than 540,000 bottles of a common thyroid medication due to potency problems that could affect treatment outcomes, according to a notice. “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform” to the agency’s manufacturing standards, the company’s “drug products are adulterated,” the FDA said in its letters to the company.
Company Expands Recall
IBSA Pharma Inc., based in Parsippany, New Jersey, expanded its voluntary recall of levothyroxine sodium tablets after additional testing revealed subpotent batches. The affected bottles include 88-microgram tablets distributed nationwide. The company said it initiated the recall to protect patients from inconsistent thyroid hormone levels that could lead to symptoms such as fatigue, weight gain, or rapid heartbeat.
FDA Warns Patients to Check Labels
The FDA urged patients to check the National Drug Code (NDC) and lot numbers on their bottles. Affected lots include codes listed in the agency’s official recall notice. Patients are advised not to stop taking their medication without consulting a healthcare provider.
Potential Health Risks
Underdosed thyroid medication can cause hypothyroid symptoms or worsen existing conditions. In sensitive populations—such as pregnant women or elderly patients—incorrect thyroid hormone levels may pose serious health risks. Pharmacists and healthcare professionals are contacting patients who may have received the recalled medication. IBSA Pharma is offering replacement products and instructions for safe returns.
Consumers can find the recall details and lot numbers on the FDA website or contact IBSA Pharma’s recall hotline for more information.
