Why it was recalled
Superpotent Drug and Subpotent Drug: potency failures obtained
Product description
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Lot numbers, UPCs & expiration codes
Lot #: a) 8171269, Exp. Date Feb 2025; 8179579, Exp. Date July 2025 b)3183815, Exp. Date Nov 2024; 3189147, Exp. Date Jan 2025; 3192027, Exp. Date Feb 2025; 3202894, Exp. Date Jul 2025; 3192026, Exp. Date Feb 2025; 3199781, Exp. Date Jun 2025. 3192028, exp. date Feb 2025 3202895, exp. date July 2025
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-0127-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 18, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 65,169
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0127-2025, 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) 8171269, Exp. Date Feb 2025; 8179579, Exp. Date July 2025 b)3183815, Exp. Date Nov 2024; 3189147, Exp. Date Jan 2025; 3192027, Exp. Date Feb 2025; 3202894, Exp. Date Jul 2025; 3192026, Exp. Date Feb 2025; 3199781, Exp. Date Jun 2025. 3192028, exp. date Feb 2025 3202895, exp. date July 2025
- Postal code
- 15317-5853
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0127-2025
- Classification
- Class II
- Recalling firm
- Viatris Inc
- Product quantity
- 65,169
- Reason for recall
- Superpotent Drug and Subpotent Drug: potency failures obtained
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), 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