Drug recall D-0167-2025

Class II Terminated reported Jan 8, 2025

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

Reason for recall

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

Lots and codes

Lot# LA01276, Exp Date: 07/2026

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
480 1000-count bottles
Distribution
One US distributor in Ohio.
Type
Voluntary: Firm initiated
Recall initiated
December 20, 2024
Terminated
February 17, 2026

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