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Class II · ModerateRecall completed

Levothyroxine Sodium

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

Does this affect you?
Check your lot numberLot# LA01276, Exp Date: 07/2026
Where it was soldOne US distributor in Ohio.
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

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

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 byLupin Limited, Pithampur (M.P)- 454 775 INDIA foreign manufacturer
Brand nameLEVOTHYROXINE SODIUM
Generic nameLEVOTHYROXINE SODIUM
Active ingredient(s)LEVOTHYROXINE SODIUM
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States
NDC68180-967-03
Show the full FDA record
Full product labelLevothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
Recalling firmLupin Pharmaceuticals Inc.
DistributionOne US distributor in Ohio.
Quantity480 1000-count bottles
Recall initiated2024-12-20
Report date2025-01-08
Recall completed2026-02-17
Recall numberD-0167-2025
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Levothyroxine recallsRecent drug recallsCheck another medication

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.