Pfizer Levoxyl Tablets Recalled Due to Subpotency
The US Food and Drug Administration (FDA) has issued a Class II recall for Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, distributed in 100-count bottles, due to the drug being subpotent—meaning it does not meet the approved potency specifications. The affected lot, Lot #24C11, has an expiration date of February 28, 2026, and includes 29 004 bottles distributed within the United States. This formulation was manufactured in Austria and distributed by Pfizer Inc., headquartered in New York, NY. The recall was voluntarily initiated on July 29, 2025, and is ongoing.
The FDA classified the recall as Class II on August 8, 2025, which implies that use of the product may cause temporary or medically reversible health effects, but the risk of serious injury is considered low. Subpotent thyroid medication can be particularly problematic for patients who rely on precise dosing for thyroid hormone replacement therapy. Pfizer initiated the recall through formal letter notification, although no public press release has been issued at this time.
Levoxyl is a synthetic thyroid hormone indicated for the treatment of hypothyroidism, as well as TSH suppression in thyroid nodules, goiter, and certain types of thyroid cancer. Subtherapeutic doses can lead to fatigue, weight gain, depression, and cardiovascular complications in patients with hypothyroidism.
