Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: a) 3182797, Exp. Date Nov 2024; 8177587, b) 3199816, Exp. Date Jun 2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Viatris Inc
- Reason for Recall:
- Superpotent Drug and Subpotent Drug: potency failures obtained
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Product Codes/Lot Numbers:
Lot #: a) 3182797, Exp. Date Nov 2024; 8177587, b) 3199816, Exp. Date Jun 2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0118-2025
Related Recalls
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Superpotent Drug and Subpotent Drug: potency failures obtained