Why it was recalled
Super-Potent Drug: Out of specification potency results were obtained.
Product description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.
Lot numbers, UPCs & expiration codes
Lot 3116074, Exp. 09/30/2025
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-0290-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 7, 2025
- FDA report date
- Mar 26, 2025
- Quantity
- 347 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc.
Original FDA data
Every field from FDA enforcement report D-0290-2025, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 96428
- Address
- 1718 Northrock Ct
- Code information
- Lot 3116074, Exp. 09/30/2025
- Postal code
- 61103-1201
- Report date
- Mar 26, 2025
- Product type
- Drugs
- Recall number
- D-0290-2025
- Classification
- Class II
- Recalling firm
- Mylan Institutional, Inc.
- Product quantity
- 347 Cartons
- Reason for recall
- Super-Potent Drug: Out of specification potency results were obtained.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2025