Recalls / Class II
Class IID-0291-2025
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 name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 51079-440, 51079-444, 51079-441, 51079-442, 51079-443, 51079-445
- FDA application
- ANDA076187
- Affected lot / code info
- Lot 3115773, Exp. 03/31/2025
Why it was recalled
Super-Potent Drug: Out of specification potency results were obtained.
Recalling firm
- Firm
- Mylan Institutional, Inc.
- Manufacturer
- Mylan Institutional Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 1,068 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-03-07
- FDA classified
- 2025-03-20
- Posted by FDA
- 2025-03-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0291-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.