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FDA Closes Recall of Accord Healthcare Levothyroxine Tablets

The FDA has closed the Class II recall of certain levothyroxine sodium tablets due to subpotency, according to an agency enforcement report.

2 reports on this incident · first at Sep 7, 2026, 10:42 p.m. ET

By AI ReporterWritten Sep 7, 2026, 10:54 p.m. ET
The U.S. Food and Drug Administration has closed the recall of Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, according to an FDA enforcement report dated September 2, 2026. The recall, initiated August 6, 2026, was classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per the FDA's recall definitions. The recall, numbered , was issued by , , NC, for . The affected lots are D2401834, D2401982 with expiration date 08/31/2026, and D2402584, D2402585, D2402586, D2402588, D2402587, D2402589 with expiration date 11/30/2026. The product is NDC 16729-448-17, manufactured for Accord Healthcare by Intas Pharmaceuticals Limited, India. The FDA's enforcement report lists the recall status as "" as of the report date, but the agency has closed the action, meaning it considers the recall carried out. The FDA database records no other enforcement action by this firm. Consumers who have these lots should check their medication and follow any guidance from their pharmacy or healthcare provider.

Earlier reports

  1. Sep 7, 2026, 10:42 p.m. ETFirst report

    Accord Healthcare Recalls Levothyroxine Sodium Tablets Due to Subpotency

    Accord Healthcare, Inc. of Raleigh, NC, initiated a recall of Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, according to an FDA enforcement report dated September 2, 2026. The recall, identified as D-0776-2026, was initiated on August 6, 2026, and is ongoing. The reason given is "Subpotent Drug." The product is distributed nationwide within the United States.

    The affected lots are D2401834 and D2401982 with expiration date 08/31/2026, and D2402584, D2402585, D2402586, D2402588, D2402587, D2402589 with expiration date 11/30/2026. The product is manufactured for Accord Healthcare by Intas Pharmaceuticals Limited in India, with NDC 16729-448-17.

    The FDA has classified this as a Class II recall, meaning the product may cause temporary or medically reversible harm and the probability of serious adverse health consequences is remote, according to the FDA's recall definitions. The FDA enforcement report lists no other enforcement actions for this firm.

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Revision history

  1. Version 18 Sept 2026, 02:42current

    First published.

  2. Version 18 Sept 2026, 02:54current

    First published.

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