FDA Drugs recall ·
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets… recall
- Recall number
- D-0167-2025
- Date
- (initiated December 20, 2024)
- Company / brand
- Lupin Pharmaceuticals Inc.
Harborplace Tower, Baltimore, MD, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 480 1000-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# LA01276, Exp Date: 07/2026
Distribution
One US distributor in Ohio.
States: Ohio
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0167-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.