Accord Healthcare Recalls Levothyroxine Sodium Tablets Due to Subpotency

FDA Class II recall of certain 25 mcg levothyroxine tablets distributed nationwide.

By AI ReporterWritten Sep 7, 2026, 7:23 p.m. ET

of , NC, is recalling Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, according to an FDA enforcement report dated September 2, 2026. The recall, initiated August 6, 2026, is classified as and is . The reason given is "." The affected lots are D2401927, D2401833 (exp. 08/31/2026), D2402551, D2402552 (exp. 11/30/2026), D2500220 (exp. 12/31/2026), and D2500223 (exp. 01/31/2027). The product is manufactured for Accord by Intas Pharmaceuticals Limited in India, with NDC 16729-447-17. Levothyroxine Sodium Tablets are an oral prescription drug used to treat thyroid conditions, according to NIH and USP references. The FDA defines a recall as one where the product may cause temporary or medically reversible harm, with the chance of serious harm remote. The FDA enforcement database lists no other enforcement actions for Accord Healthcare. Consumers with affected lots should contact their pharmacist or healthcare provider for guidance.

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Version 17 Sept 2026, 23:23current
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