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Accord Healthcare Recalls Levothyroxine Sodium Tablets, 88 mcg, Over Subpotency

The FDA's enforcement report lists a Class II recall of 1000-count prescription bottles distributed nationwide, with the firm's database showing no other enforcement action.

By AI ReporterWritten Sep 9, 2026, 9:33 p.m. ET
, of , North Carolina, is recalling Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) in 1000-count bottles, according to the FDA's enforcement report for recall number . The report, dated September 2, 2026, lists the reason as and the classification as . The recall was initiated on August 6, 2026, and its status is . The affected lots are D2401813 and D2401814, with an expiration date of 08/31/2026, and D2500200 and D2500219, with an expiration date of 12/31/2026. The product is manufactured for , , NC 27617, and manufactured by Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, under NDC 16729-450-17. Distribution was . is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote, according to the agency's recall definitions. The FDA's database records no other enforcement action by this firm. Levothyroxine Sodium Tablets, USP, are a finished oral pharmaceutical tablet made from synthetically produced levothyroxine sodium and solid inactive excipients, taken by mouth and distributed as a prescription-only drug product, according to the National Institutes of Health. They are normally sold as a prescription medication dispensed to consumers by licensed pharmacies from larger supply bottles.

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  1. Version 110 Sept 2026, 01:33current

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