FDAClass IIMarch 26, 2025

Levothyroxine Sodium Tablets recall

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan…

Why was Levothyroxine Sodium Tablets recalled?

Super-Potent Drug: Out of specification potency results were obtained.

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 3115773, Exp. 03/31/2025

Product
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan…
Recalling firm
Mylan Institutional, Inc.
Quantity
1,068 cartons
Distribution
Nationwide in the USA
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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