FDA Recall D-0128-2025
Viatris Inc · Canonsburg, PA
Class II Ongoing 542 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, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason for recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Recall record
- Recall number
D-0128-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States and Puerto Rico
- Recall initiated
- 2024-11-18
- Classified by FDA Center
- 2024-12-12
- FDA published
- 2024-12-18
- Recalling firm
- Viatris Inc
- Firm location
- Canonsburg, PA
Drug identification
- Brand name(s)
- LEVOTHYROXINE SODIUM
- Generic name(s)
- LEVOTHYROXINE SODIUM
- Manufacturer(s)
- Mylan Pharmaceuticals Inc.
- NDC(s)
0378-1800, 0378-1803, 0378-1805, 0378-1807, 0378-1809, 0378-1811, 0378-1813, 0378-1823, 0378-1815, 0378-1817, 0378-1819, 0378-1821- 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.