Why it was recalled
Superpotent Drug and Subpotent Drug: potency failures obtained
Product description
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Lot numbers, UPCs & expiration codes
Lot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024
Where it was sold
Nationwide within the United States and Puerto Rico
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-0128-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 18, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 35,883 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0128-2025, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95768
- Address
- 1000 Mylan Blvd
- Code information
- Lot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024
- Postal code
- 15317-5853
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0128-2025
- Classification
- Class II
- Recalling firm
- Viatris Inc
- Product quantity
- 35,883 bottles
- Reason for recall
- Superpotent Drug and Subpotent Drug: potency failures obtained
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Distribution pattern
- Nationwide within the United States and Puerto Rico
- Recall initiation date
- Nov 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 12, 2024