FDA Upgrades Recall of Levothyroxine Sodium Tablets Due to Lower-Than-Advertised Strength
The Food and Drug Administration today upgraded a recall for over 54,000 bottles of levothyroxine sodium tablets, a medication commonly used to treat hypothyroidism, after discovering the tablets may not contain the advertised dosage.
According to an updated enforcement report, 54,532 bottles of “Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only,” with NDC 16729-450-15, were recalled because they were sub-potent. The recall was initially issued on September 16, but was elevated to a Class II recall yesterday, October 9, 2025. Class II recalls, as defined by the FDA, pose a temporary or reversible health risk, or have a remote chance of serious adverse effects.
The affected medication was manufactured for Accord Healthcare, Inc., of Raleigh, North Carolina, by Intas Pharmaceuticals Limited in India. This recall follows a similar action on July 14, 2025, involving over 160,000 bottles of levothyroxine sodium tablets also produced by Intas Pharmaceuticals. Levothyroxine sodium is a hormone therapy used to address hypothyroidism, a condition where the thyroid gland doesn’t produce enough thyroid hormone, potentially leading to fatigue, weight gain, and other health issues if left untreated.
The FDA advises patients currently taking the recalled medication to continue doing so but to consult with their healthcare provider for guidance and potential alternative treatments. The agency will continue to investigate the issue and provide updates as they become available.
