FDA Drug recall D-0126-2025
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10),…
- FDA Drug
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10),… by Viatris, citing superpotent Drug and Subpotent Drug: potency failures obtained.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0126-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-18 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
Product
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason
Superpotent Drug and Subpotent Drug: potency failures obtained
Identifiers
| ndc | 0378-1800-77 |
|---|---|
| ndc | 0378-1800-10 |
| ndc | 0378-1803-77 |
| ndc | 0378-1803-10 |
| ndc | 0378-1805-77 |
| ndc | 0378-1805-10 |
| ndc | 0378-1807-77 |
| ndc | 0378-1807-10 |
| ndc | 0378-1809-77 |
| ndc | 0378-1809-10 |
| ndc | 0378-1811-77 |
| ndc | 0378-1811-10 |
| ndc | 0378-1813-77 |
| ndc | 0378-1813-10 |
| ndc | 0378-1823-77 |
| ndc | 0378-1823-10 |
| ndc | 0378-1815-77 |
| ndc | 0378-1815-10 |
| ndc | 0378-1817-77 |
| ndc | 0378-1817-10 |
| ndc | 0378-1819-77 |
| ndc | 0378-1819-10 |
| ndc | 0378-1821-77 |
| code_info | Lot # a) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Ja…Lot # a) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Jan 2025; 3184929, Exp. Date Dec 2024; 3204909, Exp. Date Aug 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0126-2025%22
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