FDAHealthMarch 7, 2025
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morg
⚠️ Super-Potent Drug: Out of specification potency results were obtained.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 7, 2025
Nationwide in the USA
What's affected?
- Product
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
- Brand
- LEVOTHYROXINE SODIUM
- Lot code
- 3115773
Additional details
Lot 3115773, Exp. 03/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,068 cartons.
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