Some patients taking a widely used thyroid medication may have received pills that were weaker than the dose their doctors prescribed. The Food and Drug Administration classified a nationwide recall of levothyroxine sodium tablets as Class II on July 17 after routine stability testing found the pills were subpotent.
According to Healthline, Lupin Pharmaceuticals manufactured the tablets, while Major Pharmaceuticals and Cardinal Health distributed them. The recall covers 12 products in seven dosage strengths, ranging from 25 micrograms to 150 micrograms.
An FDA Class II recall is considered a medium-risk action. It applies to products that may cause temporary or reversible health problems, with a low probability of serious harm.
Major Pharmaceuticals informed its wholesale customers in a letter dated July 10 that the recall was initiated due to out-of-specification results found during routine stability testing for Assay, meaning the pills contained less of the active ingredient than required. That letter, shared with Healthline, stated that use of the product "is not likely to cause adverse health effects." It also told wholesale customers their cooperation was "necessary to prevent patient harm."
The affected lots distributed by Major Pharmaceuticals include a 25 mcg lot expiring July 2026, three separate 75 mcg lots, an 88 mcg lot expiring January 2027, and others spanning 50, 112, 125, and 150 micrograms with expiration dates ranging from July 2026 through January 2027. Cardinal Health distributed five of the seven strengths under a separate set of lot numbers and packaging formats, including both bag and blister pack configurations.
The tablets began shipping on January 22, 2025.
Patients who have been prescribed the medication are encouraged to continue taking it while they consult their doctors. Pharmacies are not required to notify patients directly about the recall.
Anyone concerned about whether their prescription is part of the affected lots can check the lot number and NDC code printed on their bottle against the list published in the FDA's enforcement report.
