Class II
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.
Super-Potent Drug: Out of specification potency results were obtained.
- Recall number
- D-0291-2025
- Report date
- March 26, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Mylan Institutional, Inc.
- Generic names
- LEVOTHYROXINE SODIUM
- Brand names
- LEVOTHYROXINE SODIUM
- Product NDCs
- 51079-440, 51079-444, 51079-441, 51079-442, 51079-443, 51079-445
Code and lot information
Lot 3115773, Exp. 03/31/2025
Distribution
Nationwide in the USA
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.