Hypothyroidism Medication Recalled Over Impurity Concerns
Lupin Pharmaceuticals, Inc., headquartered in Baltimore, Maryland, has initiated a voluntary Class II recall of Levothyroxine sodium tablets, 75 mcg (0.075 mg), due to failed impurities and degradation specifications.
Lot #LA01276, with an expiration date of July 2026, was found to have out-of-specification impurity results during a 3-month long-term stability study. The recall affects 480 bottles of 1000 tablets each, distributed through a single distributor in Ohio. The recall was initiated on December 20, 2024.
A Class II recall indicates that use of the affected product may lead to temporary or reversible health issues, with a low risk of severe harm. In this case, the failure to meet impurity and stability specifications could affect the medication’s efficacy and safety. Levothyroxine sodium is a prescription drug used to treat hypothyroidism; a condition characterized by insufficient thyroid hormone production.
