Why it was recalled
Subpotent and Superpotent Drug
Product description
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20
Lot numbers, UPCs & expiration codes
Lot #: 3115936, Exp. Date 07/2025
Where it was sold
Nationwide in the USA.
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-0131-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 19, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 2,835 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc.
Original FDA data
Every field from FDA enforcement report D-0131-2025, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 95817
- Address
- 1718 Northrock Ct
- Code information
- Lot #: 3115936, Exp. Date 07/2025
- Postal code
- 61103-1201
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0131-2025
- Classification
- Class II
- Recalling firm
- Mylan Institutional, Inc.
- Product quantity
- 2,835 cartons
- Reason for recall
- Subpotent and Superpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Nov 19, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 12, 2024