Class II · ModerateActive recall
Levothyroxine Sodium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 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 soldNationwide within the United States and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Superpotent Drug and Subpotent Drug: potency failures obtained
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMylan Pharmaceuticals Inc.
| Brand name | LEVOTHYROXINE SODIUM |
| Generic name | LEVOTHYROXINE SODIUM |
| Active ingredient(s) | LEVOTHYROXINE SODIUM |
| Distributed by / for | Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A |
| NDC | 0378-1809-77 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Viatris Inc |
| Distribution | Nationwide within the United States and Puerto Rico |
| Quantity | 65,169 |
| Recall initiated | 2024-11-18 |
| Report date | 2024-12-18 |
| Recall completed | — |
| Recall number | D-0127-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Canonsburg PA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.