A thyroid medicine is being recalled at the FDA's highest risk level − and it's causing confusion and concern among the many Americans who use such medications to manage thyroid conditions.
The recall applies to one lot of thyroid tablets sold by Vitruvias Therapeutics Inc., which accounts for thousands of units distributed nationwide.
The 30mg thyroid tablets are labeled "Thyroid Tablets, USP" and have an expiration date of Sept. 30, 2026. They were distributed nationwide between Jan. 31 and Sept. 30, 2025.
About 1,900 units were sold from a batch of about 3,600, according to the notice, and can be identified by the National Drug Code number 69680-166-00 or lot number 504950.
"This product is an off-white to pale brown, round tablet, which may
display flecks. One side of the tablet is debossed with the letters 'THY' and the other side is debossed with '050,'" Vitruvias shared in a statement to USA TODAY.
The company clarified that the recalled product is not “Levothyroxine” or “Synthroid®”. These are dosed in micrograms.
This could explain why there's been some confusion around the recall.
Levothyroxine is "one of the most commonly prescribed drugs in the United States, with approximately 7% of the population estimated to have an active prescription," according to a Mayo Clinic post in 2023.
To complicate matters further, there was a separate recall of levothyroxine a few months ago. So if patients are searching for information on the current recall, they may be confusing it with an outdated recall.
How serious is the current thyroid medication recall?
The U.S. Food and Drug Administration categorized the recall as a Class I recall, its highest risk level, on Sept. 22.
A Class I recall indicates that using the product is likely to cause serious health effects or death, according to the agency.
The recall was issued because the medication could be superpotent, or stronger than intended, according to the original recall notice published by the FDA on Aug. 24.
Consuming superpotent thyroid tablets can cause an overactive thyroid and issues like weight loss, heat intolerance, fatigue and hypertension, according to the notice.
Anyone taking the recalled tablets should contact their health care provider for guidance, according to the FDA notice.
Consumers with questions can contact Vitruvias Therapeutics by email at safety@vitruvias.com or by phone at 256-239-9373.
Contributing: Melina Khan
This article originally appeared on USA TODAY: Thyroid medicine recall sparks concern, confusion. Here's what to know
