D-0167-2025 Class II Terminated
FDA drug recall D-0167-2025 was initiated by Lupin Pharmaceuticals Inc. on Dec 20, 2024 and is designated Class II. 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. The recall status is terminated (terminated Feb 17, 2026). Affected quantity: 480 1000-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 8, 2025
- Initiation Date
- Dec 20, 2024
- Termination Date
- Feb 17, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 1000-count bottles
Product Description
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.
Distribution Pattern
One US distributor in Ohio.
Code Information
Lot# LA01276, Exp Date: 07/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0167-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026