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Accord Healthcare Recalls Levothyroxine Sodium Tablets, 100 mcg, Over Subpotency

The FDA's enforcement report lists a Class II recall of specific lots of the prescription thyroid drug, distributed nationwide, for a subpotent drug.

By AI ReporterWritten Sep 9, 2026, 9:38 p.m. ET
of , North Carolina, is recalling Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) because the drug is subpotent, according to the FDA's enforcement report for recall number . The recall was initiated on August 6, 2026, and reported on September 2, 2026, and its status is . The affected product is packaged in 90-count bottles (NDC 16729-451-15) and 1000-count bottles (NDC 16729-451-17), and is labeled Rx Only. It was manufactured for , , NC 27617, by Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. The FDA's enforcement report lists the following lots and expiration dates: Lot D2402186, Exp. Date 09/30/2026; Lot D2402019, Exp. Date 08/31/2026; Lot D2402094, Exp. Date 09/30/2026; and Lots D2500022, D2500023, D2500021, Exp. Date 12/31/2026. The recall is classified as , which the FDA defines as the category used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. Distribution was . Levothyroxine Sodium Tablets, USP, 100 mcg is an oral solid finished drug product made from synthetically manufactured levothyroxine sodium blended with inactive pharmaceutical excipients, packaged as standard solid tablets in plastic bottles and distributed to consumers through pharmacies, according to the National Institutes of Health. It is normally sold as a prescription-only pharmaceutical. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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  1. Version 110 Sept 2026, 01:38current

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