FDA Issues Class II Recall for Multiple Strengths of Levothyroxine Tablets Due to Subpotency
The US Food and Drug Administration (FDA) has announced a Class II recall of multiple Levothyroxine Sodium Tablets, USP strengths—ranging from 25 mcg to 175 mcg—due to assay results below approved potency specifications. The recall includes more than 160 000 bottles across several lots and formulations, with expiration dates extending through March 2026. The affected products were manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare, Inc., headquartered in Raleigh, North Carolina. The recall was voluntarily initiated on June 20, 2025, and applies to products distributed nationwide in the United States.
The FDA classified the recall as Class II on July 14, 2025, indicating that while the use of subpotent levothyroxine may lead to temporary or medically reversible adverse health consequences, the risk of serious harm is considered low. Pharmacists should check inventory for the affected lot numbers across NDCs 16729-447 through 16729-456 and ensure the removal of subpotent products. No press release has been issued; however, Accord Healthcare has notified consignees through formal communication channels to support the safe retrieval of products.
Levothyroxine is a synthetic thyroid hormone used to treat hypothyroidism and for TSH suppression in thyroid cancer or nodular disease. Subpotent doses can lead to inadequate thyroid hormone replacement, potentially causing symptoms such as fatigue, weight gain, depression, and cardiovascular complications.
