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.
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
Lot numbers, UPCs & expiration codes
Lot# LA01276, Exp Date: 07/2026
Where it was sold
One US distributor in Ohio.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0167-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2024
- FDA report date
- Jan 8, 2025
- Quantity
- 480 1000-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0167-2025, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 95892
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot# LA01276, Exp Date: 07/2026
- Postal code
- 21202-6174
- Report date
- Jan 8, 2025
- Product type
- Drugs
- Recall number
- D-0167-2025
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 480 1000-count bottles
- Termination date
- Feb 17, 2026
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- One US distributor in Ohio.
- Recall initiation date
- Dec 20, 2024
- Initial firm notification
- Center classification date
- Dec 30, 2024