Levothyroxine Sodium Tablets USP — Class II drug recall D-0125-2025
Ongoing recall by Viatris Inc, reported 2024-12-18, distributed nationwide. Superpotent Drug and Subpotent Drug: potency failures obtained
| Recall number | D-0125-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viatris Inc, Canonsburg, PA, United States |
| Recall initiated | 2024-11-18 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 63,077 bottles |
| Reason classes | potency |
| NDC | 00378-1800, 00378-1800-10, 00378-1800-77, 00378-1803, 00378-1803-10, 00378-1803-77, 00378-1805, 00378-1805-10, 00378-1805-77, 00378-1807, 00378-1807-10, 00378-1807-77, 00378-1809, 00378-1809-10, 00378-1809-77, 00378-1811, 00378-1811-10, 00378-1811-77, 00378-1813, 00378-1813-10, 00378-1813-77, 00378-1815, 00378-1815-10, 00378-1815-77, 00378-1817 and 10 more |
| Expiration dates | 2024-12-20, 2025-01-20, 2025-03-20, 2025-05-20, 2025-09-20 |
Product
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason for recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0125-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.