Accord Healthcare Recalls Levothyroxine Sodium Tablets Due to Subpotency

FDA classifies recall of certain 200 mcg levothyroxine sodium tablets as Class II, citing subpotent drug.

By AI ReporterWritten Sep 7, 2026, 10:53 p.m. ET

of , NC, initiated a recall of Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg) on August 6, 2026, according to an FDA enforcement report dated September 2, 2026. The recall, numbered , is classified as and is . The reason given is "." The product was distributed . The affected product is packaged in 90-count bottles (NDC 16729-457-15) and 1000-count bottles (NDC 16729-457-17). The recall covers lots D2402430, D2402431, D2402432 (expiration 10/31/2026) and D2500180 (expiration 12/31/2026). The product is manufactured for Accord Healthcare by Intas Pharmaceuticals Limited in India. The FDA defines a recall as one where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The FDA enforcement database lists no other enforcement actions by Accord Healthcare. The cause of the subpotency has not been determined.

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