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Class II · ModerateActive recall

Levothyroxine Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot 3115773, Exp. 03/31/2025
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameLEVOTHYROXINE SODIUM
Generic nameLEVOTHYROXINE SODIUM
Active ingredient(s)LEVOTHYROXINE SODIUM
Distributed by / forMylan Institutional, Inc.
NDC51079-443-20
Show the full FDA record
Full product labelLevothyroxine 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 Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
Recalling firmMylan Institutional, Inc.
DistributionNationwide in the USA
Quantity1,068 cartons
Recall initiated2025-03-07
Report date2025-03-26
Recall completed—
Recall numberD-0291-2025
ClassificationClass II
FDA statusOngoing
Origin on fileRockford IL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.