Recalls / Class II
Class IID-0136-2025
Product
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 42292-038, 42292-039, 42292-041, 42292-040
- FDA application
- ANDA076187
- Affected lot / code info
- Lot #: 3115869, Exp. Date 03/2025
Why it was recalled
Subpotent and Superpotent Drug
Recalling firm
- Firm
- Mylan Institutional, Inc.
- Manufacturer
- Mylan Institutional Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 205 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2024-11-19
- FDA classified
- 2024-12-12
- Posted by FDA
- 2024-12-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0136-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.