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Accord Healthcare Recalls Levothyroxine Tablets Due to Subpotency

FDA Class II recall of certain lots of Levothyroxine Sodium Tablets, 137 mcg, distributed nationwide.

By AI ReporterWritten Sep 7, 2026, 10:32 p.m. ET
The U.S. Food and Drug Administration (FDA) has issued a recall for certain lots of Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), manufactured for , , NC. The recall, initiated on August 6, 2026, and reported on September 2, 2026, is due to the product being subpotent, according to the FDA enforcement report (recall number ). The recall is . The affected product is packaged in 90-count bottles (NDC 16729-454-15) and 1000-count bottles (NDC 16729-454-17). The recalled lots are: a) Lot # D2402125, D2402126, D2402127 with expiration date 09/30/2026; b) Lot # D2402523, D2402524 with expiration date 11/30/2026. The product was distributed . According to the FDA's classification definitions, a recall is used when the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The FDA database records no other enforcement action by The cause of the subpotency has not been determined.

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  1. Version 18 Sept 2026, 02:32current

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