December 2024 FDA Recall Levothyroxine Sodium by Lupin Pharmaceuticals Inc.
D-0167-2025 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 20, 2024 for the product Levothyroxine Sodium. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in One US distributor in Ohio. and the recall is currently terminated.
Recall Number: D-0167-2025
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
12-20-2024
01-08-2025
480 1000-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
One US distributor in Ohio.
02-17-2026
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# LA01276, Exp Date: 07/2026
