Levothyroxine recalled nationwide by FDA; Earlier studies claim over 20 million Americans are 'unnecessarily' taking this thyroid medication

The US Food and Drug Administration (FDA) has issued a nationwide recall of levothyroxine sodium after discovering the medication may not meet its required potency standards. According to ‘The Telegraph’, the recall, which began on July 13, has been designated as a Class II recall, meaning use of the affected product could cause temporary or medically reversible health problems. Levothyroxine sodium is the generic form of the thyroid hormone replacement medication used to treat hypothyroidism and other conditions caused by an underactive thyroid. It works by replacing thyroxine (T4), a hormone the body cannot produce in sufficient amounts.

The recall has also renewed attention on the widespread use of levothyroxine. Earlier research has suggested that millions of Americans may be prescribed the medication without a clear medical indication, sparking ongoing discussions about potential overtreatment. The FDA classifies a Class II recall as a situation in which a product may cause temporary or medically reversible health effects, while the risk of serious or life-threatening consequences is considered low. This category indicates that the issue should be addressed but does not necessarily require patients to stop using the medication immediately. For recalled levothyroxine sodium products, the FDA advises patients to continue taking their medication unless instructed otherwise by the agency, the manufacturer, or their healthcare provider.

According to the FDA, the recalled levothyroxine tablets were distributed in 10-tablet blister packs, either sold separately or packaged in cartons containing 10 blister packs for a total of 100 tablets. The affected products include strengths of 25 mcg, 50 mcg, 75 mcg, 88 mcg, 112 mcg, and 150 mcg, with expiration dates spanning July 2026 through January 2027.


Dr. Joe El-Khoury, an associate professor of laboratory medicine at Yale School of Medicine, said multiple studies have found that prescribing levothyroxine to people who do not truly need it may do more harm than good. According to Dr. Joe El-Khoury, in a letter published in Clinical Chemistry on March 1, 2023, unnecessary prescribing and overtreatment with levothyroxine may increase the risk of adverse health effects.

"The emerging evidence is very concerning because we’re actively giving patients a drug that they don’t need that can have potentially severe side effects, especially in elderly individuals over 80," said El-Khoury.

A 2021 study conducted by researchers from Yale School of Public Health, Mayo Clinic, and the University of Arkansas also raised concerns about the widespread use of levothyroxine in the United States. The researchers estimated that of the roughly 23 million Americans taking the thyroid medication, nearly 21 million - about 90% - may not have a clear medical need for the prescription.

The study warned that unnecessary use of levothyroxine can expose patients to avoidable side effects, including anxiety, heat intolerance, and diarrhea. In more severe cases, particularly among adults over the age of 80, overtreatment may increase the risk of serious cardiovascular complications and even death.