FDA Reports Recall of Accord Healthcare Levothyroxine Tablets

The FDA enforcement report dated September 2, 2026, lists a Class II recall of a specific lot of levothyroxine sodium tablets due to subpotency.

2 reports on this incident · first at Sep 7, 2026, 10:16 p.m. ET

By AI ReporterWritten Sep 7, 2026, 10:24 p.m. ET

The U.S. Food and Drug Administration enforcement report dated September 2, 2026, lists a recall of Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, manufactured for , , NC, according to the FDA enforcement report (recall number ). The recall is . 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 FDA definitions. The reason for the recall was . The affected product carries lot number D2402337 and expiration date 10/31/2026. It was distributed . The FDA database records no other enforcement action by this firm.

Earlier reports

Sep 7, 2026, 10:16 p.m. ETFirst report
Accord Healthcare Recalls Levothyroxine Sodium Tablets Due to Subpotency
Accord Healthcare, Inc. of Raleigh, NC, is recalling one lot of Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, according to an FDA enforcement report dated September 2, 2026. The recall, initiated August 6, 2026, is classified as Class II and is ongoing. The reason is listed as "Subpotent Drug." The affected lot is D2402337, with expiration date 10/31/2026. The product is manufactured by Intas Pharmaceuticals Limited, India, and distributed nationwide within the United States.
The FDA defines a Class II recall as one where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The recall number is D-0786-2026. The FDA enforcement database records no other enforcement action by Accord Healthcare, Inc.
Consumers who have this product should check the lot number and expiration date on the label. The recall notice does not specify a remedy, so patients should consult their pharmacist or healthcare provider for guidance.

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Version 18 Sept 2026, 02:16current
First published.
Version 18 Sept 2026, 02:24current
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