Accord Healthcare Recalls Levothyroxine Sodium Tablets Due to Subpotency

FDA Class II recall of certain 125 mcg levothyroxine tablets distributed nationwide.

By AI ReporterWritten Sep 7, 2026, 7:26 p.m. ET

The U.S. Food and Drug Administration (FDA) published an enforcement report on September 2, 2026, detailing a recall initiated by of , NC. The recall, numbered , covers Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), supplied in 1000-count bottles (NDC 16729-453-17). The reason cited is "." The recall is and was initiated on August 6, 2026. The affected lots are D2401983 (exp. 08/31/2026), D2402640 and D2402641 (exp. 11/30/2026), and D2500224 (exp. 01/31/2027). The product is manufactured for Accord Healthcare by Intas Pharmaceuticals Limited in India and was distributed . According to the FDA's recall classification definitions, is a situation where use of the product may cause temporary or medically reversible adverse health consequences, and where the probability of serious adverse health consequences is remote. The FDA enforcement database lists no other enforcement actions for The agency's report does not specify the quantity of product affected.

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Version 17 Sept 2026, 23:26current
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