FDA Recall D-0136-2025
Mylan Institutional, Inc. · Rockford, IL
Class II Ongoing 541 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Subpotent and Superpotent Drug
Recall record
- Recall number
D-0136-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2024-11-19
- Classified by FDA Center
- 2024-12-12
- FDA published
- 2024-12-18
- Recalling firm
- Mylan Institutional, Inc.
- Firm location
- Rockford, IL
Drug identification
- Brand name(s)
- LEVOTHYROXINE SODIUM
- Generic name(s)
- LEVOTHYROXINE SODIUM
- Manufacturer(s)
- Mylan Institutional Inc.
- NDC(s)
42292-038, 42292-039, 42292-041, 42292-040- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.