Lupin Pharmaceuticals Inc. recalls Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals,…

Recall date

December 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0167-2025

FDA classification

Class II

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

One US distributor in Ohio.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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