FDAClass IIOctober 15, 2025

Levothyroxine Sodium Tablets recall: Subpotent

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617…

Why was Levothyroxine Sodium Tablets recalled?

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # D2300045, Exp 12/31/2025.

Product
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617…
Recalling firm
ACCORD HEALTHCARE, INC.
Quantity
54,432 bottles
Distribution
Nationwide in the US
Recall date
October 15, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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