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) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Jan 2025; 3184929, Exp. Date Dec 2024; 3204909, Exp. Date Aug 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 | 0378-1807-77 |
Show the full FDA record
| Full product label | Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), 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 | 43,765 bottles |
| Recall initiated | 2024-11-18 |
| Report date | 2024-12-18 |
| Recall completed | — |
| Recall number | D-0126-2025 |
| 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.