Class IITerminated

Levothyroxine Sodium Tablets recall

FDA recall D-0167-2025 · initiated Dec 20, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: Levothyroxine 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 company: Lupin Pharms
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: One US distributor in Ohio.
Initiated: Dec 20, 2024
FDA report date: Jan 8, 2025

This recall is linked to a product we cover: Levothyroxine Sodium →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0167-2025 ↗

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